NCCL Direct Composite Restoration Performance With Self-Etch and Multimode Adhesives Clinical Trial
Phase: NA
Conditions: Dental Adhesives/Restorations Performance
Sponsor: University Fernando Pessoa

 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
 
Official Title: NCCL Direct Composite Restoration Performance with Self-Etch and 
Multimode Adhesives Clinical Trial  
 
NCT ID: NCT02698371 
Protocol ID- CEIC/INFARMED: FCS-UFP-2014-04-2015-07-19 
 
 
 
 
Date: 4th August 2015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NCT02698371 
 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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INDEX 
1 – Introduction……………………………………………...…………………………1 
 
Objectives and hypothesis…………………………………………………...…..5 
2 – Population, Materials and Methods (SAP)…….……………………………..…..6 
3 – Project Schedule …………………………………………………………………..16 
4 – Necessity Estimates……………………………………………...………………...17 
5 - References…………………..………………………………...……………………18 
6- Annexes……………………………………………………………………………..21 
Annex 1- Inform Consent Form to participants………………………………….……22 
Annex 2- Participants/Restorations Clinical/Research File…………………..……….25 
Annex 3- FDI (World Dental Federation) criteria ………………………….…………29  
Annex 4- USPHS (Modified U.S Public Health Service) criteria…………….……….32 
 
 

 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
TABLES INDEX 
 
Table 1 - Control (G1, G2) and study arms/ groups (G3, G4, G5, G6) of NCCL 
restorations randomized allocated according to adhesion mode and application 
procedures………………………………………………………………………………9 
Table 2 - Information regarding Medical devices, Manufacturers, Lot# Number, 
Composition, adhesives pH value (according to manufactures and medical devices 
safety 
data 
sheet)……………………………………………………………………………….…10 
 
 
 
 
 
  

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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1 - INTRODUCTION 
 
Historically, dental adhesives have been broadly divided into total-etch (TE), etch-and-
rinse (ER) and self-etch (SE) adhesives (1–3). Total-etch are considered the gold-
standard adhesive systems on enamel bonding rendering the most pronounced etch 
patterns on cut and uncut enamel. 
Self-etching adhesive systems, or “self-etch”(SE) as are usually called, were developed 
in the beginning of years ninety, with main purpose to simplify, even more, the clinical 
steps comparatively with the available adhesive systems (ER) in the market. SE primers 
are systems constituted by an acidic primer and a fluid resin and SE adhesives function 
as all-in-one systems, as a solution that demineralised and impregnates the resin in the 
demineralised layer, in only one step (1,4,5). SE adhesives use acidic monomers, with 
different pH values, to demineralise/modify dentin and enamel patterns while, 
simultaneously, primers/resins  infiltrate into demineralised tissues and dentin tubules 
(6).  
Few data exists with respect to mean and long-term observational clinical performance 
of SE all-in-one adhesive systems (7). However, their clinical use is increasing (8), 
contributing to this growth the fact of being user-friendlier (shorter application time, 
less clinical steps), less technique-sensitive (no wet-bonding, simple drying), and the 
perception that SE adhesives cause less postoperative sensitivity than ER adhesives. 
This argument is manly supported by their less aggressive (when compared to 
phosphoric-acid pH value) regarding acidity and, thus more superficially interaction 
with dentin occurs, leaving tubules largely obstructed with smear layer (6). However, 
some of those factors are controversial regarding some clinical outputs (9). SE 
adhesives would result in poorer enamel marginal integrity than TE/ER adhesives, since 
the integrity and durability of the enamel bond, particularly to uncut enamel, is the weak 
link for these materials. One-step SE adhesives showed higher bond strengths on 
ground enamel and no reductions in resin-enamel bonds were observed after 12 months 
of water storage. Marginal adaptation was significantly better for Clearfil S3 Bond than 
for Adper Prompt L-Pop, according to  in vitro findings (10). 
More recently, some researchers and dental adhesive manufacturers advocate the 
selective enamel etching technique, by which phosphoric acid is selectively placed on 
cut or uncut enamel during 15 seconds and then rinsed. The entire preparation is dried, 
and a self-etching adhesive system is applied and light-cured (11,12). Some laboratorial 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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results indicate that intact enamel pre-treatment, by etching with 37% phosphoric acid 
resulted in longer resin tags and higher depth of penetration of resin tags of the adhesive 
bond, achieving higher bond strength outputs to intact enamel (13). Pre-etching enamel 
may enhance the bond strength of SE adhesive systems to values comparable with those 
found with ER adhesives, which may improve their overall performance in clinical use 
(12). 
The actual bonding performance reached by SE adhesives are widely and some 
controversially reported, depending on the SE adhesives system characteristics 
regarding their composition and more specific on functional monomers included in 
adhesive formulations (3,6,10). According to a systematic review that explore the 
clinical performance of adhesives, Peumans and colleagues found less favourable 
clinical performance in the SE bonding strategies compared with an ER protocol. 
Krithikadatta also performed a review (clinical trials from 2004 to 2010 years) on the 
clinical effectiveness of contemporary dentin bonding agents and concluded that the 
clinical performance of different categories of bonding system were comparable (14). 
However, and according to that author, not all the reviews presented full details 
regarding their methodology and review/assessment process; different conclusions 
reached in these studies may be explained by the rigorous selection criteria and robust 
quality assessment, during clinical practice and restorations clinical performance 
observation. Recently, a systematic review included studies with low overall risks of 
bias and reported favourable mean-term (2–3 years) clinical performance for all four 
bonding strategies regarding restoration retention. The included studies showed wide 
variation on clinical performance between adhesives with the same bonding strategy/ 
use mode and, the authors concluded that there was insufficient evidence to make firm 
recommendations for the use of one adhesive system or bonding strategy over another. 
The proportion of information obtained from studies with an unclear or high risk of bias 
was high. Studies with low overall risk of bias found good clinical performance for 
adhesives with three-step ER (ER-3), two-step ER (ER-2), two-step SE (SE-2) and one-
step SE (SE-1) bonding strategies/mode. There is a need for future research on clinical 
effectiveness of adhesive systems and adhesives mode use, in particular, a better 
standardisation and reporting of randomised controlled trials and, restorations 
performance during clinical practice, that allows a more meaningful comparison 
between adhesives (3). 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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New “universal” or “Multi-Mode” (MM) adhesives have been introduced in the market 
and designed to be clinically used by ER or by SE modes. In general, these MM 
adhesives are more hydrophobic than previous SE products to address permeability 
issues. The bond strengths to dentin in both, ER and SE, modes are very good. Bond 
strengths to enamel are reasonable but to ensure long-term durability, the selective-etch 
technique (etching of enamel only) is recommended for universal adhesives (15). 
Multimode one-bottle universal adhesives have been developed recently to make the 
clinical procedure even more user-friendly. These systems can be used for both direct 
and indirect restorations (16) and provide the flexibility for the clinician to select and 
choose the adhesive use mode (ER or SE) according to the clinical and dental hard 
tissues conditions. From a marketing perspective MM adhesives are highly innovative 
products offering the clinician the liberty of adapting a single-bottle SE adhesive for use 
as ER mode or as selective enamel etching (SE-EE) adhesion mode without 
compromising its bonding effectiveness (17). Controversy remains on, if these versatile 
adhesives contain technological advances for overcoming challenges associated with 
previous generations of adhesives or adhesion modes, since the available data mainly is 
based on in vitro findings. The concept behind these adhesives is novel; hence, only few 
short/mean-term clinical (16,18–20) and, immediate ultra-morphological and bond 
strength studies (21–25) have been reported. Some laboratory findings revealed that 
performance of universal multimode adhesives was shown to be material-dependent 
(23). Despite being considered user-friendly, acidity adjustment of MM adhesive 
solutions and incorporation of new functional monomers to promote clinical 
performance stability over time were the main changes proposed to improve these 
materials. Perdigao and colleagues observed during 18th month the clinical performance 
of the MM adhesive, Scotchbond Universal Adhesive (3M ESPE, St Paul, MN, USA) in 
non-carious cervical lesions (NCCLs) and concluded that, restorations retention with 
this universal adhesive was not dependent on the bonding strategy. Differences between 
use modes were detected only for adhesive restorations marginal adaptation, by FDI 
criteria (World Dental Federation- clinical criteria for direct/indirect restorations 
evaluation), but not by the USPHS (United States Public Health Service) criteria (16). 
Controversy remains about the use of MMP inhibitors to control the degradation of 
dentin-resin interfaces (26). According to the adhesion-decalcification (A-D) concept 
aggressive demineralization of hard tissues by strong acids results in dissolution of 
apatite crystallites, decreasing the opportunity to establish chemical bonds between SE 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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adhesives functional resin monomers (10-MDP- methacryloyloxydecyl dihydrogen 
phosphate) and apatite crystallites, and the potential for creating nano-layers of calcium 
precipitates with phosphate resin monomers. However, resin–dentine interfaces created 
by contemporary MM adhesives containing 10-MDP may not be as immune to 
degradation as the manufacturers would like (17). Adhesives with MDP (Clearfil SE 
Bond, Kuraray; Scotchbond Universal, 3M ESPE) in their composition can chemically 
bond to Ca++ ions and form stable MDP-Ca salts, according to the “adhesion-
decalcification” concept, which may be responsible for the good long-term performance 
of MDP-containing adhesives on dentin, both in vivo and in vitro outputs. Thus, the 
enamel selective-etch technique is especially recommended for MDP-containing 
universal adhesives (15). However, dental adhesives are complex mixtures usually 
containing several monomers. Yoshida and colleagues investigated the effect of HEMA 
(2-hydroxyethylmethacrylate) monomer on the chemical interaction of MDP with 
hydroxyapatite (HAp) by x-ray diffraction (XRD), nuclear magnetic resonance (NMR), 
and quartz crystal microbalance (QCM). Authors examined the chemical interaction of 
5 experimental MDP solutions with increasing concentrations of HEMA. XRD revealed 
that addition of HEMA inhibits nano-layering at the interface, while NMR confirmed 
that MDP remained adsorbed onto the HAp surface. QCM confirmed this adsorption of 
MDP to HAp as well as revealed that, the demineralization rate of HAp by MDP was 
reduced by HEMA. Thus, the authors concluded that even though the adsorption of 
MDP to HAp was not hindered, addition of HEMA inhibited interfacial nano-layering 
so, potential consequences with regard to bond durability necessitate further research 
(27). 
Recently, dentalAEGIS stated Ivoclar Vivadent’s Adhese® Universal with VivaPen® 
as an effective delivery for all etching/adhesive methods; Tysowsky describes the 
characteristics of the material itself as technique-tolerant and predictable. It forms a 
stable and homogenous layer that is not sensitive to any application method. “Its 
hydrophilic solvent, which is acetone-free, provides for optimum wetting of the dentin 
and enamel, which leads to enhanced infiltration and optimum sealing of the dentinal 
tubules, preventing microleakage and associated postoperative sensitivity” (28). 
Although the role of in vitro data to predict clinical performance is increasingly 
recognised, randomised controlled trials (RCTs) remain the most rigorous study design 
for assessing the clinical effectiveness of an intervention, a health product or a medical 
device, especially when they are already commercially available.  The majority of 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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studies investigating the clinical effectiveness of bonding systems use the longevity of 
restorations in NCCLs as the outcome (3). These are widely available and are normally 
used in clinical research, for assessment of adhesive systems (26,29) performance and 
efficacy, because NCCLs present no macro-mechanical retention, they present margins 
in enamel and/or dentin, and restorations are exposed to high stress during masticatory 
function (3,17), are located mainly in dentine, facilitating evaluation of the resin–
dentine bond which is less stable than the resin–enamel bond (3).  
The overarching goal of this RCT is to compare clinical performance at 24th month 
recall, of two MM adhesives from different manufactures, applied by SE or ER modes, 
with an SE-all-in-one adhesive (by SE or SE-EE modes) in NCCLs, using both USPHS 
and FDI criteria. 
 
Objectives and Hypothesis 
 
The purpose is to evaluate/compare clinical effectiveness of dual cure (DC) all-in–one 
Self-Etch (Futurabond®DC-FBDC) adhesive and the multimode (MM) (FuturabondU® 
-FBU- and Adhese®Universal –ADU-) adhesives, with or without selective enamel 
etching, in NCCL restorations, at 24th months follow-up, using Word Dental Federation 
(FDI) and United States Public Health Services (USPHS) criteria. 
The null hypotheses are: 
H0 – Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM 
adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) 
clinical (aesthetic, functional and biologic) behaviour/performance; 
H0 – Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar 
restorations (aesthetic, functional and biologic) success rates; 
H0 – Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in 
similar restoration retention rates; 
H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; 
G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no 
significant 
differences) 
clinical 
(aesthetic, 
functional 
and 
biologic) 
behaviour/performance; 
H0 – Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar 
restorations (aesthetic, functional and biologic) success rates; 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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H0 – Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar 
restoration retention rates; 
H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU 
(G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no 
significant 
differences) 
clinical 
(aesthetic, 
functional 
and 
biologic) 
behaviour/performance; 
H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-
curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, 
functional and biologic) success rates; 
H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-
curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention 
rates; 
H0 - FDI or USPHS criteria evaluation outcomes not differ for the same data, at 24th 
month follow-up. 
 
2 – POPULATION, MATERIALS AND METHODS 
 
2.1- TRIAL DESIGN 
 
The trial design follows the Consolidated Standards of Reporting Trials (CONSORT) 
statement (30). Prospective, double blind, clinical trial; randomized allocation of NCCL 
restorations by six adhesion interventional groups (6 arms) for examination of 
restorations performance. 
Study will take place in University Fernando Pessoa - Faculty of Health Sciences (UFP-
FHS), Dentistry School Clinic. Participants recruitment between November 2015 and 
April 2016. Restorations estimated to be done until April or May 2016 year. 
The study is scheduled to last 24th months. Baseline clinical observation will be done 30 
days after placement of adhesion restoration (First data research); a second appointment 
after 12th months (second data; data not to be included on final report, according to the 
main purpose and trial hypothesis to study) and the last research evaluation will be at 
24th months after baseline (Final data/report). Clinical trial may continue for similar 
assessment intervals, after 24th months evaluation. This situation requires new analysis 
according to the clinical and economics conditions, at that time. 
 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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2.2- POPULATION AND PARTICIPANT SELECTION 
 
All participants will be informed (Written and verbal Inform Consent, Annex 1) about 
the trial conditions and purposes, but will not be aware of what tooth will received the 
adhesion treatment strategy under evaluation. Written informed consent form (Annex 
1), according to World Medical Association Declaration of Helsink (31), will be 
obtained from all participants prior to starting the treatment.  University Fernando 
Pessoa Ethics Committee review (Annex 2) and approved the present protocol.  This 
clinical trial is done according to the European Union law for clinical research and 
National Law for Clinical Research (Law 21/2014, of 16 April), and was analysed, 
approved and authorized by the National Competent Authorities (Annex 2): 
- 
CNPD, Portuguese Data Protection Authority (Authorization and registry 
6430/2015 at 7 July 2015; Case 2536/2015). 
- 
CEIC, National Ethics Committee for Clinical Research (N.º 20150305; 
Approved at 3th August 2015)  
- 
INFARMED, National Authority of Medicines and Health Products, IP (N.º 
EC/011/2015; DPS/DM/450.10.053/2015/0314; Authorization at 4th August 
2015) 
The decision to participate in this study is voluntary (Annex 1) as well as the decision to 
refuse participation and decision of withdrawal of the same, at any time of the study 
respecting all the rights of the patient/participant. Given the purpose of this study, and 
the fact of existing multiple and several market therapeutic alternative for this type of 
interventions, the fact of participate in this study will not involve any additional cost, 
except the one described in the fee schedule of Dentistry School Clinic-UFP. They will 
not be granted any incentives or financial benefits (payment of travel or counter-parties) 
to participate in the trial. The participant has as cost the "restoration of the tooth surface, 
which of course would have to make even not participating in this investigation, as 
regulated for the clinical practice. The clinical observations, temporarily established (3 
appointments in 24th month) to observe participants and evaluate the research 
restorations performance, will be free of charge for the participants. All other acts that 
the participant needs or intends to perform, not included in the protocol of this trial, 
should meet the same, the fees charges of Dentistry School Clinic-UFP. Dental 
restorations are applied to tooth surfaces requiring intervention/repair for the 
maintenance of dental structure in oral cavity of the patient. The operator (Dentist and 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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Associate Professor of FHS-UFP) inform the patient/participant in all aspects related to 
the study. Refusal of patient participation, the participant's withdrawal and revocation of 
consent to participate in this study are rights of the patient/participant, without any 
consequences or reprisal, and without interference in the relationship between users and 
teachers/researchers/ University and clinical entities. 
Patients with ages of 18 up to 65 years which voluntary come to Dentistry School Clinic 
of Faculty of Health Sciences – UFP will be recruited in the order in which they are 
report for appointment, thus forming a convenience sample. According to assessed 
eligibility (inclusion and exclusion) criteria, volunteers will be selected for this study as 
recommended, by CONSORT guidelines (30). A minimum of 210 restorations will be 
performed, randomized in order to be allocated to six interventions, named as adhesion 
intervention groups (Table 1).  
 
In this study will be included participants with clinical diagnosis of tooth structure 
coronal loss and needs for cervical (vestibular surface) restoration without chemical or 
bacterial origin, called non-carious cervical lesion (NCCL) located in pre- 
molars/molars (PM/M) teeth, with cavity dimensions defined in the study design. 
Therefore, restorations can be made in PM or M teeth; a participant can have up to 16 
teeth (8PM + 8M) with NCCL. The number of teeth to restore by participant will be of 
maximum of 6 and a minimum of one NCCL, within this clinical trial. The allocation of 
the study arms (G1 to G6) to a particular tooth is randomly allocated, with the 
information available to the operator/principal investigator in sealed envelopes and 
previously prepared by the investigator-statistics. The allocation of the study arms (G1, 
G2, G3, G4, G5, G6) to each tooth by participant is performed randomly, but ensuring 
that the distribution of the groups is not repeated in the same participant. For this 
purpose, will be organized by the statistical investigator, 210 envelopes with 35 
sequences of 6 study arms, where in each order of 6 groups is randomized. 
If the patient has more than six teeth that meet the inclusion criteria, the selection of the 
PM and M teeth to be included in the clinical trial will be conducted randomly by 
scenarios randomized by the statistical investigator after participation and contact for 
the effect (not done a priori, since it is necessary 19448 scenarios prior randomization 
before observing any patient, whereas the possible teeth to be selected for treatment is 
between 6 and 16 and the teeth to select from 6). 

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NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
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The participant has as cost the academic/scientific fees, as in usual clinical context of 
Dentistry School Clinic of Faculty of Health Sciences – UFP as "restoration of a tooth 
surface"/ by tooth to restore (One to six teeth), which of course would have to make 
even not participating in the investigation, as the Dentistry School Clinic fee scale. 
The restorations included in this trial will be evaluated for determine clinical 
performance from baseline to 24th month by the three calibrated examiners. These 
observation appointments (three, in two years) as part of the clinical trial will be free of 
charges for participants. Baseline and 24th month data will be statistically analysing, 
according to this trial purpose and hypothesis.   
 
2.3- STUDY ADHESION ARMS 
 
Study adhesive NCCLs restorations are randomly distributed to 6 groups (6 
arms/interventions), according to adhesive (product) and adhesion mode (SE, ER) of 
use, as show in table 1.  
 
Table 1 - Control (G1, G2) and study arms/ groups (G3, G4, G5, G6) of NCCL 
restorations randomized allocated according to adhesion mode and application 
procedures. 
Control and study Groups 
and NCCL restoration 
distribution (n)  
Adhesives 
System_Mode 
Application Procedures 
G1 (Control group) 
n=35 
FBDC_SE 
Mixture Liquid 1 into Liquid 2 (1:1 ratio). Apply and rub this 
homogeneous mixture to enamel and dentine for 20 seconds; 
Air-blow for 5 seconds; light cure (1000mW/cm2), for 20 
seconds. 
G2 (Control group) 
n=35 
FBDC, SE with 
enamel etching 
(FBDC_SE-EE) 
Apply etchant selectively on enamel and leave for 30 seconds. 
Thoroughly rinse for 1 minute and gently dry. Dentine surface 
must slightly remain wet. Mixture Liquid 1 into Liquid 2 (1:1 
ratio). Apply and rub this homogeneous mixture to enamel and 
dentine for 20 seconds; Air-blow for 5 seconds; light cure 
(1000mW/cm2), for 20 seconds. 
G3 
n=35 
FBU_ER  
Apply etchant for 30 seconds on enamel and 15 seconds on 
dentine; Thoroughly rinse for 1 minute and gently dry. Dentine 
surface remain with silky matt appearance. Apply and rub 
adhesive for 20 seconds, and air-blow for 5 seconds; light-
cured (1000mW/cm2) for 20 seconds. 
G4 
n=35 
FBU_SE  
Apply and rub adhesive for 20 seconds, and air-blow for 5 
seconds; light-cured (1000mW/cm2) for 20 seconds. 
G5 
n=35 
ADU_ER  
Apply etchant for 30 seconds on enamel and 15 seconds on 
dentine; Thoroughly rinse for 1 minute and gently dry. Dentine 
surface remain dry. Scrubbed adhesive for at least 20 seconds; 
Air-blow to disperse adhesive until a glossy, immobile film 
layer results; Light-cure (1000mW/cm2) for 20 seconds. 
G6 
n=35 
ADU_SE  
Scrubbed adhesive for at least 20 seconds; Air-blow to disperse 
adhesive until a glossy, immobile film layer results; Light-cure 
(1000mW/cm2) for 20 seconds. 
FBDC: Futurabond® DC; FBU: Futurabond® U; ADU: Adhese® Universal; SE: Self-Etch; ER: Etch-and-Rinse 
 

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NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
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2.4- OPERATOR / EXAMINERS CALIBRATION 
 
For the operator calibration procedure, operator will do one restoration of each group in 
order to identify all steps involved in the application technique. This procedure will be 
done three times, with one week, interval. All restorations done by the same calibrated 
operator. Three experienced and calibrated dentists, not involved with the restoring 
procedures and therefore blinded to the group assignment, will perform the clinical 
evaluation. For training purposes, the examiners observed 10 photographs that were 
representative of each score for each criterion, in 10 cervical restorations (not included 
in this trial), each one, on two consecutive days. An intra-examiner and inter-examiner 
agreement will be calculated. 
Medical devices composition according to manufactures, Voco and Ivoclar Vivadent 
safety data sheets for adhesives and products is show in Table 2. 
 
Table 2 - Information regarding Medical devices, Manufacturers, Lot# Number, 
Composition, adhesives pH value (according to manufactures and medical devices 
safety data sheet). 
Medical Device 
(manufacture) 
Lot#Number  
Composition 
Futurabond® DC (FBDC) 
(Voco, Cuxhaven, Germany) 
Lot# 1532592 
Liquid 1. Acidic adhesive monomer*; BIS-GMA (5-10%), 2-HEMA (5-10%);  
Liquid 2. Ethanol (50-100%); Initiator (2.5-5%) 
Mixture. organic acids, BIS-GMA, 2-HEMA, TMPTMA, campherchinon, 
amines (DABE), BHT, catalysts, fluorides and ethanol  
pH-value 1.5 
Futurabond® U (FBU) 
(Voco, Cuxhaven, Germany) 
Lot# 1543141 
Liquid 1. (2-HEMA) (25-50%); BIS-GMA (25-50%); HEDMA (10-25%); 
Acidic adhesive monomer (5-10%)*; UDMA (5-10%); catalysts (≤ 2.5%), 
silica nanoparticles;  
Liquid 2. Ethanol (50-100%); Initiator (2.5-5%); catalysts (≤ 2.5) 
pH-value 2.3 
Vococid®  
(Voco, Cuxhaven, Germany) 
Lot# 152135 
35% orthophosphoric acid  
Adhese® Universal (ADU) 
(Ivoclar Vivadent AG, 
Liechtenstein) 
Lot# U35131 
Liquid: 2-HEMA (10-<25%); Bis-GMA (10-<25%); ethanol (10-<25%); 1,10-
decandiol dimethacrylate  (3-<10%); Methacrylated phosphoric acid ester (3-
<10%); campherquinone (1-<2.5%); 2-dimethylaminoethyl methacrylate (1-
<2.5%); 2-dimethylaminoethyl methacrylate (0.1-<2.5%). 
pH-value 2.5-3.0 
Admira® Fusion 
(Voco, Cuxhaven, Germany) 
Lot# (Shade A1, A2, A3, A3,5) 
1508270, 150827, 1510508, 
1509381 
Nano-hybrid ORMOCER®s (organically modified ceramics); large and 
precondensed molecules of an inorganic matrix with a high degree of cross-
linking. 84 % w/w inorganic fillers. Silicon oxide forms the chemical base, not 
only for the fillers (nanofillers as well as glass ceramics) but also for the resin 
matrix.  
*Acidic adhesive monomer (10-MDP: 10-methacryloyloxydecyl dihydrogen phosphate according to Voco manufacture); Bis-
GMA-Bisphenol A glycidil methacrylate; HEMA-hidroxyethil methacrylate; UDMA- Urethane dimethacrylate 
 
 
 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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2.5- DATA REGISTRY/PROTECTION AND RESTORATIONS PROCEDURES 
 
Photographs (digital data registration) will be carried out by the operator/responsible for 
research, strictly made to NCCL cavities and restorations as part of this trial. No 
photographs will be made to identify the patient, including photographs of the patient 
face or profile. All photographs taken in the context of this study will be "identified" 
(file name) with a single key (alphanumeric key without any kind of relationship with 
file number, name, date of birth or other information associated with the participant 
patient). Only in the registration database (with access to the principal investigator and 
other team members, with the exception of the statistical investigator for the purposes of 
observational clinical records) there should be registration/membership of this key with 
the code-process of patients. The database in question will be lodged in own servers 
with restricted access levels and well identified. The servers that lodge the photos/ 
records and the database belong to Dentistry School Clinic of Faculty of Health 
Sciences – UFP and are located in datacentre with fully controlled access. This 
mechanism ensures the concealment of identity of the user (as name and other 
information identifying the participant) in the photographs and other records file, having 
access to them only the investigator and research team (except investigator of statistics). 
This mechanism fulfilled the recommendation and Authorisation of CNPD, Portuguese 
Data Protection Commission Authority (Authorization and registry 6430/2015 at 7 July 
2015; Case 2536/2015). 
 
Appointment and restorative procedures, in accordance with the following steps:   
One week, before the Restorative procedure (1st appointment): Inform the patient 
(Written/Verbal- Anexx-1); Patient signature of informed consent; Fulfilment of the 
project clinical file (patient identification, general clinical summary, oral clinic 
examination, oral hygiene state; Annex 2); Dental prophylaxis with fluoride toothpaste 
and water with a nylon brush. Vitality tests (cold and hot) executed with spray Endo 
cool (ethyl chloride) and warm instrument; Pre-operative sensitivity evaluation by 
applying air for 10 seconds from a dental syringe placed 2 cm from the tooth surface 
(16); NCCLs cavities will be evaluated according to the degree (1, 2, 3, 4) of sclerotic 
dentin (32), cavity dimensions (H-height, W-width, and D-depth) in millimetres (mm) 
and geometry (evaluated by profile photograph, as Angles Acute (A), Severe (S), 
Obtuse (O) (16); 

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1st Appointment-Intervention: Initial intra-oral/cavity surface and tooth digital 
photography; Teeth anaesthesia with 3% mepivacaine (Scandinibsa, Sintra Business 
Park, Portugal); Operatory field isolation with cotton rolls and retraction floss 
(Ultradent). All cavities cleaned with pumice and water in a rubber cup, followed by 
rinsing and drying. Selection composite colour by shade guide; Adhesive interventions 
according to G1 to G6 arms assignment. Adhesive systems will be used as SingleDose 
mode. Composite restorations (AdmiraFusion Universal nano-hybrid composite) with 
incremental filling technique (two increments maximum), light-cured (LED Unit) with 
an intensity of 1000mW/cm2, during 40 seconds. Restorations will be finished 
immediately with diamond disks (OptiDisc® medium 40μm; Kerr) and burns. Polishing 
performed with diamond-impregnated silicone polishers (Dimanto, Voco, CuxHaven) 
during 10 seconds. Intra-oral digital photography of the restoration.  
 
2.6- CLINICAL RECALL 
Baseline (30 days after restoration), 12th and 24th months Appointments 
1 - Intra-oral digital photography of the NCCL restoration; 
2- Pos-operative sensitivity evaluation by applying air for 10 seconds from a 
dental syringe placed 2 cm from the tooth surface (16); 
3 – Clinical direct evaluation by 3 calibrated examiners according to FDI (33) 
(Annex 3) and USPHS (34) (Annex 4); 
4º- Data register. 
 
Study variable definition – Clinical/direct observation and performance evaluation 
acceptance by means of FDI (FDI World Dental Federation - clinical criteria for the 
evaluation of direct restorations) (Adapted from (33) (Annex 3) and USPHS (34) 
(Annex 4). 
  
2.7- DATA AND STATISTICAL ANALISYS PLAN (SAP) 
 
Data statistical analysis and description according to aims of this trial; Specific program 
for statistical data analysis (IBM(c) SPSS(c) Statistics vs. 22 or later) will be used. 
The changes in parameters clinical performance (paired comparison analysis) by both, 
FDI and USPHS criteria will be assessed by McNemar or Wilcoxon tests, for both 

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primary and secondary outcomes, to determine differences between treatments with 
regard to aesthetic, functional and biological parameters from baseline to 24th month 
recall (longitudinal assessment). Differences will be considered to be significant at 
P<0.05. Whenever 3 groups will be compared at 24 months’ recall, a Kruskal Wallis 
test will be used and upon significant differences detection, then Mann-Whitney tests 
considering Bonferroni correction will be used for pairwise group comparisons. 
Comparison of FDI and USPHS acceptance (success rate) criteria evaluation outcomes 
for Esthetic, for Functional and for Biological Parameters, at 24th Month Follow-up, 
were compared using the chi-square test. 
If missing data occurs, that is, if dropouts or non-observed due to loss of retention of the 
restoration, then the paired comparison will consider for the baseline just the 
restorations existing at the last moment (24 months).  
 
2.8- OBSERVATIONS REGARDING SAMPLE CALCULATION 
 
It was assumed that the minimum number of adhesive restorations to be held in each of 
the six arms (G1 to G6) is 35 (210 restorations). The researchers did not have detailed 
information that allows the estimation of the sample size based on power analysis (the 
effect of the expected difference to the end of the time considered for the study). Thus, 
in principle they assumed the rules of thumb, usually considered in research situations 
where there is no advance information concerning the performance evaluation of these 
adhesive medical devices available on the market, using this assay. Moreover, when 
considering a "simple" analysis comparison using a McNemar test (repeated measures) 
in six groups would be necessary in total, including at least 80 cases (to restore teeth) in 
the sample. When considering at least 35 restorations by group, researchers are greatly 
increasing the minimum number stipulated in the aforementioned technique. In 
addition, clinical studies previously performed on this issue (between 2004 and 2012) 
relative to the post-market clinical evaluation performance of adhesive products/use 
mode in NCCLs, in the context of restorative dentistry field, has enabled to measure a 
minimum of 30 restorations as viable for determining events in a short/mean-term as the 
clinical performance evaluation of a similar nature of adhesives. 
 
 
 

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2.9- GOOD CLINICAL PRACTICE FOR CLINICAL RESEARCH  
 
Reporting mechanism of possible adverse incident during the investigation will be held 
according to Medical Devices (MD) commercially available in the market, so it 
interprets and assumes the issue as applicable to assumptions in the Portuguese National 
Law for Clinical Research (Article 22) 21/2014, of 16 April, calling up a mechanism for 
reporting any incidents inherent to medical devices or resulting from the use of medical 
devices. In this way, and considering the type of intervention to carry out in this 
research (restoration of very small extension of NCCL with dental adhesives), the 
medical devices (Adhesive systems) are not described in the literature and not known 
records for the occurrence of undesirable incidents, with interpretative effects as Serious 
or Unexpected “adverse incidents". However, and according to good clinical practice 
for clinical research, the reporting mechanism of Serious or Unexpected incidents 
(protocol version FCS-UFP-2014-04-2015-07-19) for this research are approved by 
CEIC (National Ethics Committee for Clinical Research (N.º 20150305; Approved at 3th 
August 2015), as followed: 
1º - Clinical knowledge of the incident taken by the principal investigator; 
2º- Register of occurrence and possible reasons associated with it; 
3º- Clear Information to the participant about the serious or unexpected adverse 
occurrence, providing urgent measures as may be appropriate to safety protect the 
subjects against any immediate risk or any fact relating to the conduct of the trial. 
 4º - The investigator notifies the clinical Director and the Sponsor within 24 hours of 
all serious or unexpected events, and the defects of devices that could have led to a 
serious adverse event, except those conditions that are identified in the protocol (loss of 
retention of the adhesive restoration) or in the investigator's brochure as not requiring 
immediate reporting; 
5º- Investigator presents to the sponsor a detailed written report, within five days. 
6º - The Sponsor ensure that: 
a) All important data regarding serious adverse events related to the clinical trial, 
which has caused or may cause death or severe deterioration of the health status 
of participants, users or third parties involved in the study, they are recorded and 
notified to the National Authorities INFARMED (National Authority of 
Medicines and Health Products, IP) and CEIC (National Ethics Committee for 

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Clinical Research), immediately and not more than two days from the moment 
in which aware of them; 
b)- Another type of adverse events, in particular regarding defects of medical 
devices that could have led to a serious adverse event and new data on any 
adverse event is recorded and notified National Authorities, INFARMED 
(National Authority of Medicines and Health Products, IP) and CEIC (National 
Ethics Committee for Clinical Research), within a period of seven days, starting 
from the moment they become aware of them. All supervening information 
considered relevant by the competent authorities will be notified within eight 
days from the closing date provided for in the preceding paragraph. 
7º - The investigator sends to the sponsor, the CEIC and INFARMED any additional 
information that may be requested. 
8º- Sponsor keeps detailed records of all adverse events, which are reported to him, by 
any investigator. 
9º- Other suspected serious and unexpected adverse events are reported by the sponsor 
to the CEIC, INFARMED and CNPD within 15 days from its notice by the promoter. 
Sponsor reports annually to CEIC and INFARMED a list of all suspected serious 
adverse events, during this period as well as a report on the safety of participants, if 
applicable. Under the study protocol (Version FCS-UFP-2014-04-2015-07-19), all the 
possible non-serious adverse events such as, clinical signs or symptoms associated with 
loss of aesthetic, functional and biological performance of restorations and situations 
described in the instructions, labelling and safety data sheets of medical devices or even, 
without incident and security maintenance data of the participants the sponsor notifies 
the CEIC and INFARMED, only by the final evaluation of this study (24th month of 
clinical performance), as set forth in article 24th of Law 21/2014 of 16 April, which will 
include a report of suspicious occurrences and safety records and, if applicable, in the 
clinical trial in the period evaluation of 24th month. Or annually, if the CEIC advise, 
even in the absence of adverse events or information, justifying changes to the safety of 
participants. 
 
 
 
 
 

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3. PROJECT SCHEDULE 
 
Estimation DATES  
Estimation ACTIVITIES 
Initial date- 6 month 
Bibliographical research on the subject to approach; 
 
December 2014 – July 2015 
 
Accomplishment of the clinical trial protocol; Order of 
authorization to the Deontological and Ethical Committee 
and Scientific Direction of University Fernando Pessoa and 
National Ethics Committee (December 2014). National 
Data Base Registration (January 2015); Authorization 
request to National Ethics Committee (CEIC); Infarmed 
Registration Clinical trials. 
September 2015 – May 2016 
(Jun 2016-Nov 2016) 
Sample trial constitution (Participants selection); Clinical 
evaluation (USPHS and FDI) through calibrate intra-
examiner and inter-examiner (First Direct evaluation: 
Baseline results, 1st month after restoration). Elaboration of 
database for statistical analysis.  
First Baseline Results);  
November 2016 – May 2017 
Second Direct evaluation, 12th month after restoration. 
 
November 2017 – May 2018 
(Jun 2018-May 2019) 
Third Direct evaluation, 24th month after restoration. 
Elaboration of statistical analysis.  
-Last Results, 24th month. 
Reports to INFARMED, CEIC (Baseline to 24th month 
follow-up). 
 
 
 
 
 
 
 
 

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4.  NECESSITY ESTIMATES 
Material/Medical Devices/ Appointments/ Methods/other Needs 
(description) 
Estimated 
Cost  
(Euro-€) 
Composite to 210 NCCL restorations (Ormofil or other)- Shades A1, A2, A3; 
Futurabond DC (Voco); Futurabond U (Voco); 4 Ivoclar Vivadent’s Adhese® 
Universal with VivaPen® 
300.00€ 
Availability of a dental equipment, Medical Devices (manual turbine, drills, 
hand instruments, sculpture instruments) for operatory field isolation, for 
technical procedures, and evaluation appointments (Digital Photographic 
machine Canon EOS 20D) in Dentistry School Clinic of Faculty of Health 
Sciences, UFP for attendance and restoration treatments of the patients;  
8,400.00€ 
Operator /Examiners and Coordination Research (Human Resources Time)  
5,950.00€ 
- Logistic Support (clinical document, information to the patient and informed 
consent forms), Phone calls, internet to contact patient; Administrative work. 
600.00 € 
- Support of biostatistics department of the FHS-UFP (database elaboration; 
data statistical analysis and description according to aims of this trial; 
Participation on the elaboration/presentation of posters and manuscript- Use 
of the specific program for statistical data analysis (IBM(c) SPSS(c) Statistics 
vs. 22.). 
1,500.00 € 
 Observational Trial in clinical Field 
16,750.00€ 
Outputs to International Presentations and Manuscripts submissions  
 
 
 
 
 
 
 
 
 

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KL. State of the art of self-etch adhesives. Dent Mater [Internet]. 2011 Jan 1 
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Burrow M, Tyas M. A clinical trial comparing two all-in-one adhesive systems 
used to restore non-carious cervical lesions: results at one year. Aust Dent J 
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Perdigão J, Swift EJ. Critical appraisal: post-op sensitivity with direct composite 
restorations. J Esthet Restor Dent [Internet]. 2013 Aug [cited 2018 Nov 
20];25(4):284–8.  
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Perdigão J, Geraldeli S, Hodges JS. Total-etch versus self-etch adhesive: effect 
on postoperative sensitivity. J Am Dent Assoc [Internet]. 2003 Dec [cited 2018 
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10.  
Owens BM, Johnson WW. Effect of Single Step Adhesives on the Marginal 
Permeability of Class V Resin Composites. Oper Dent [Internet]. 2007 Jan [cited 
2018 Nov 20];32(1):67–72.  
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Devarasa GM, Subba Reddy VV, Chaitra NL, Swarna YM. Self-etching adhesive 
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Erickson RL, Barkmeier WW, Kimmes NS. Bond strength of self-etch adhesives 
to pre-etched enamel. Dent Mater [Internet]. 2009 Oct [cited 2018 Nov 
20];25(10):1187–94.  

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13.  
Poggio C, Scribante A, Della Zoppa F, Colombo M, Beltrami R, Chiesa M. Shear 
bond strength of one-step self-etch adhesives to enamel: effect of acid 
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Krithikadatta J. Clinical effectiveness of contemporary dentin bonding agents. J 
Conserv Dent [Internet]. 2010 Oct [cited 2018 Nov 20];13(4):173.  
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Yoshida Y, Yoshihara K, Nagaoka N, Hayakawa S, Torii Y, Ogawa T, et al. Self-
assembled Nano-layering at the Adhesive Interface. J Dent Res [Internet]. 2012 
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Perdigão J, Kose C, Mena-Serrano A, De Paula E, Tay L, Reis A, et al. A New 
Universal Simplified Adhesive: 18-Month Clinical Evaluation. Oper Dent 
[Internet]. 2014;39(2):113–27.  
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Chen C, Niu LN, Xie H, Zhang ZY, Zhou LQ, Jiao K, et al. Bonding of universal 
adhesives to dentine-Old wine in new bottles? J Dent [Internet]. 2015;43(5):525–
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Mena-Serrano A, Kose C, De Paula EA, Tay LY, Reis A, Loguercio AD, et al. A 
New Universal Simplified Adhesive: 6-Month Clinical Evaluation. J Esthet 
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Loguercio AD, De Paula EA, Hass V, Luque-Martinez I, Reis A, Perdigão J. A 
new universal simplified adhesive: 36-Month randomized double-blind clinical 
trial. J Dent [Internet]. 2015;43(9):1083–92.  
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Lawson NC, Robles A, Fu C-C, Lin CP, Sawlani K, Burgess JO. Two-year 
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10];43(10):1229–34.  
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Perdigão J, Sezinando A, Monteiro PC. Laboratory bonding ability of a multi-
purpose dentin adhesive. Am J Dent [Internet]. 2012 Jun [cited 2017 Aug 
2];25(3):153–8.  
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Hanabusa M, Mine A, Kuboki T, Momoi Y, Van Ende A, Van Meerbeek B, et al. 
Bonding effectiveness of a new “multi-mode” adhesive to enamel and dentine. J 
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Tuncer D, Basaran S, Halacoglu DM, Yamanel K, Celik C, Arhun N. Effect of 
haemostatic agent application on the shear bond strength of contemporary/multi-
mode adhesive systems. Oral Heal Dent Manag. 2014;Mar;13(1):103–6.  
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Marchesi G, Frassetto A, Mazzoni A, Apolonio F, Diolosà M, Cadenaro M, et al. 
Adhesive performance of a multi-mode adhesive system: 1-Year in vitro study. J 
Dent. 2014;42(5):603–12.  

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26.  
Perdigão J. Dentin bonding-Variables related to the clinical situation and the 
substrate treatment. Dent Mater. 2010;26(2):24–37.  
27.  
Yoshida Y, Yoshihara K, Hayakawa S, Nagaoka N, Okihara T, Matsumoto T, et 
al. HEMA Inhibits Interfacial Nano-layering of the Functional Monomer MDP. J 
Dent Res [Internet]. 2012 Nov 11 [cited 2018 Nov 20];91(11):1060–5.  
28.  
Ivoclar Vivadent’s Adhese® Universal with VivaPen®: effective delivery for all 
etching methods. Compend Contin Educ Dent [Internet]. 2014 Apr [cited 2018 
Nov 20];35(4):282.  
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Van Meerbeek B, Perdigão J, Lambrechts P, Vanherle G. The clinical 
performance of adhesives. J Dent [Internet]. 1998 Jan [cited 2017 Aug 
2];26(1):1–20.  
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Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 
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32.  
Ritter A V, Heymann HO, Swift EJ, Sturdevant JR, Wilder AD. Clinical 
Evaluation of an All-in-one Adhesive in Non-Carious Cervical Lesions with 
Different Degrees of Dentin Sclerosis. Oper Dent [Internet]. 2008;33(4):370–8.  
33.  
Hickel R, Roulet JF, Bayne S, Heintze SD, Mjör IA, Peters M, et al. 
Recommendations for conducting controlled clinical studies of dental restorative 
materials [Internet]. Vol. 11, Clinical Oral Investigations. 2007 [cited 2018 Feb 
7]. p. 5–33.  
34.  
Schmalz G, Ryge G. Reprint of Criteria for the clinical evaluation of dental 
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2];9(4):215–32.  
 
LINKS: 
 
INFARMED - http://www.infarmed.pt/portal/page/portal/INFARMED/ENGLISH 
CEIC - http://www.infarmed.pt/portal/page/portal/CEIC/English 
CNPD- https://www.cnpd.pt/english/index_en.htm 
 

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ANNEXES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ANNEX 1 
Inform Consent Form to Participants  
(English translation from Portuguese version) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INFORMED CONSENT FORM TO PARTICIPATE IN FCS-UFP CLINICAL TRIAL  
 
 
 
 
 
        1.2.1.1.2- Information and Informed Consent 
Sponsor: University Faculty of Health Sciences, UFP, FFP (FCS-UFP-FFP) 
Principal Investigator: Patrícia Manarte-Monteiro (Associate Professor FCS-UFP, Medical Dentist) 
Team: Joana Domingues; Liliana Teixeira; Sandra Gavinha (Dentists); Conceição Manso (Statistics). 
Please read the following information carefully. If you feel that something is incorrect or unclear, do 
not hesitate to ask for more information. If you agree with the proposal we have made, please, sign / 
date this document. 
 
Title of the study: NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives 
Clinical Trial: observational study in clinical field. 
 
Background and Objectives: This clinical trial aims to evaluate the performance of self-etch and universal 
adhesives (with or without selective acid-enamel etching) by observing (and recording) the clinical behaviour 
of restorations that will be performed in dental cavities (from non-carious cervical lesions -LCNC) for a period 
of 2 years using the FDI and USPHS criteria. This essay has not commercial purposes, but academic / scientific 
objectives, and will be carried out at the FCS-UFP-FFP (CP-FCS) pedagogical clinic, having as principal 
investigator and as team, dentists that are FCS-UFP faculty members. 
 
Study’s explanation: In this trial, patients who voluntarily attend PC-FCS will be invited to participate, if 
they present the following conditions: diagnosis and need for restoration of dental cavities (non-retentive, 
deeper than 1mm, involving enamel and dentin in vital teeth without mobility, the cavo-superficial margin 
can not involve more than 50% of the enamel) in the cervical area of the vestibular surface (NCCLs), in the 
premolar / molar teeth. As it was defined in the design of this trial, patients with one of the following 
conditions can’t participate: Less than 20 teeth in the oral cavity, Non-vital Tooth, Advanced Periodontal 
disease, Patient unavailability to return to follow-up visits, Simultaneous participation in another current 
clinical trial, medical history, psychiatric or pharmacotherapy likely to compromise the protocol, Pregnancy, 
Allergies and / or idiosyncratic responses to the products constituents, Patient under fixed orthodontic 
treatment, Teeth prepared for fixed prosthetic rehabilitation treatments, Teeth or support structures with 
pulpal injury, periodontal surgery in the previous 3 months, severe bruxism, extremely poor oral hygiene or if 
the patient voluntarily refuses to participate in the trial. The number of teeth to be restored per participant 
will be a maximum of 6 and a minimum of 1, as part of the clinical trial. There is a random distribution of the 
restorative procedures to be done in each tooth, with the information being available only to the main 
investigator / operator in sealed and previously prepared envelopes. The participant has the usual cost of 
academic / scientific fees, as it is determined on the clinical protocol of the CP-FCS-UFP, regarding the 
"restoration of a dental surface" / per tooth to be restored (1 to 6 teeth), which of course they would have to 
pay, even if they were not participating in the investigation, according to the fee schedule of CP-FCS-UFP. 
The clinical performance of the restorations included in this trial will be evaluated in three time periods 
(baseline, after 1 year, and after 2 years), by the research team described above in the CP-FCS. These recall 
visits (3 appointments, within 2 years) within the clinical trial will be free for the participants. 
 
Benefits of the Study: The restorations and techniques performed in this trial will be done according to the 
principles of conservative dental procedures and good clinical practice; being duly restored with dental 
materials (adhesives and composites commercially available on the market) as evidenced by the literature, 
clinical protocols, biocompatibility and instructions given by the manufacturers. The evaluation of 
restorations in the 2-year period allows a controlled follow-up of the behaviour of these materials in the oral 
cavity and obtained results may promote improvements in the quality of restorative dental response to the 
users, regarding the clinical selection of adhesive materials. 
 
Risks associated with the Study: No predictable risks, no discomfort or inconveniences are attributed to the 
participant. There are no reports of undesirable, unexpected and serious situations. Possible (non-serious) 
events that may arise are expected and constitute criteria for assessing the success / failure rate of adhesive 
restorations, signs and symptoms due to the absence of adhesive restorations, and that will be replaced with 
a new restoration, without any cost to the participant, during the period of the trial (2 years), since several 
therapeutic alternatives are available on the market. 
 

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Conditions and funding: The decision to participate in this study is voluntary, as well as the decision to 
refuse participation and decision to withdraw from it, at any time during the course of the study. These 
decisions are part of the rights of the participant. According to this clinical trial objectives and because there 
are on the market multiple and varied therapeutic alternatives for this type of intervention, participating in 
this study will not entail any additional cost, besides the one that is described in the CP-FCS fee schedule. No 
financial support or benefits (travel payments or counterparts) will be granted to participate in the trial. The 
participant has the cost of "restoring a dental surface" / tooth, which would naturally have to do even if 
wasn’t participating in this investigation. Clinical observation appointments, temporarily established (3 
recalls, within 2 years) to evaluate the performance of the restorations, will be free. All remaining acts that 
the patient needs or intends to perform, not included in the protocol of this trial, must be supported by the 
patient, according with the CP-FCS fee schedule. Dental restorations will be performed on the dental 
surfaces that require intervention / repair, intending the maintenance of the tooth in the oral cavity. The 
operator (Dentist and Professor of FCS-UFP) will inform the patient / participant of all aspects related to the 
study. The refusal of the patient's participation, the participant's withdrawal, as well as the withdrawal of 
consent to participate in this study, are patient / participant rights, without any consequence or reprisal, and 
without interference in the relationship between patients and teachers / researchers /entity. 
 
This clinical trial has academic and scientific scope and is sponsor by FCS-UFP-FFP. The technical and 
material procedures used are financially supported by university FCS-UFP-FFP. There is no conflict of 
interest. This study was approved by the Ethics Committee for Clinical Research (CEIC), and authorised by 
Infarmed and by the National Commission for Data Protection (CNPD). 
 
Confidentiality and anonymity: Data will be collected on the medical and oral history, clinical 
examination of the restorations, restorations / teeth photographs of the participants (only), and duly stored 
in a database, which will be kept on University FCS-UFP-FFP servers with restricted, controlled and well-
identified access levels. The mechanism ensures the confidentiality of data and concealment of the 
participant's identification (in particular the name and other data that identifies the participant), and only 
the investigator and the research team have access to them. The CNPD Authorization is No. 6430/2015. 
Presentations and scientific publications will be made with the results of this clinical trial, but the 
identification / identity data of the participant will never become public. The data encryption key will be 
destroyed one month after the end of the study (according to CNPD). 
 
Thank you very much, for your participation! 
 
 
Contact FCS-UFP: Patricia M. Monteiro (FCS-UFP Teacher) / Dentist; patmon@ufp.edu.pt; Tf .: 225 071 300 
 
  
 
 
 
-o-o-o-o-o-o-o-o-o-o-o-o-o-o-o-o-o-o- 
 
According to the Declaration of Helsinkia (2013) I was informed and clarified, by oral and written 
way, about the study in which I will participate. I declare that I have understood the descriptions 
and explanations provided, that I have been given the opportunity to put the doubts and issues that 
I considered important, and I give my consent to be a participant in this clinical trail. I am 
conscious that I may withdraw from this investigation at any time, and the refusal to participate, 
the withdrawal, or the consents´s withdrawal to participate in this study, are rights that assist me, 
without any consequence or reprisal, and without interference in my relationship with the teachers 
/ researchers / entity. I have become aware that my decision to participate in this clinical trial is 
voluntary and that participation will not entail any additional cost besides the one that is described 
in the University CP-FCS fee schedule. The operator (Dentist, Professor and Researcher of FCS-UFP) 
informed me about all aspects related to the study. In this way, I accept to participate in this trial 
and allow the data usage that I voluntarily provide, trusting that they will only be used for this 
research and the guarantees of confidentiality and anonymity given by the researcher. 
 
Porto, _____of ______________of 201_                                                 Participant’s signature: ________________________ 
  
Porto, _____of ______________of 201_                                                 Dentist/investigator signature: ___________________ 
 
THIS DOCUMENT HAS TWO PAGES AND TWO COPIES WERE MADE: ONE IS GIVEN TO THE RESEARCHER AND THE OTHER IS FOR THE PERSON WHO 
CONSENTS 
 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
25 
ANNEX 2 
Participants/Restorations Clinical/Research File  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
26 
PATIENT IDENTIFICATION  
Name_______________________________________________________________ 
Age (years) _________________ Birth date_______________ 
Date ___________________ UFP Code of patient________ 
Register of 1ª Appointment 
1- GENERAL CLINICAL EXAMINATION (Summary)  
 
 
 
 
YES 
NOT 
WHICH? 
•SISTEMIC PATHOLOGY  
 
 
 
•PHARMOTERAPHY 
 
 
 
• TABAGYC HABITS 
 
 
 
 
•ALLERGIES 
 
 
 
 
2- HYGIENE STATUS 
 
3- VITALITY AND SENSIBILITY TEST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4- DENTIN SCLEROSIS/ 5 - CAVITY DIMENTIONS (HWD) /6 – GEOMETRY  
_______________ /   H-___________W-__________D-_________/_______________ 
 
 
 
 
Good 
 
Reasonable 
 
Insufficient 
 
Vitaliy 
Test 
Tooth 
Number 
Pre-operative 
1st Month 
12th Months 
24th Months 
Yes 
No 
Yes 
No 
Yes 
No 
Yes 
No 
Cold 
 
 
 
 
 
 
 
 
 
Heat 
 
 
 
 
 
 
 
 
 
AIR 
 
 
 
 
 
 
 
 
 
Cold 
 
 
 
 
 
 
 
 
 
Heat 
 
 
 
 
 
 
 
 
 
AIR 
 
 
 
 
 
 
 
 
 
Cold 
 
 
 
 
 
 
 
 
 
Heat 
 
 
 
 
 
 
 
 
 
AIR 
 
 
 
 
 
 
 
 
 
Cold 
 
 
 
 
 
 
 
 
 
Heat 
 
 
 
 
 
 
 
 
 
AIR 
 
 
 
 
 
 
 
 
 
Cold 
 
 
 
 
 
 
 
 
 
Heat 
 
 
 
 
 
 
 
 
 
AIR 
 
 
 
 
 
 
 
 
 
Cold 
 
 
 
 
 
 
 
 
 
Heat 
 
 
 
 
 
 
 
 
 
AIR 
 
 
 
 
 
 
 
 
 
Date 
NCCL Nº 
Randomized allocated Group treatments 
Material 
 
 
1-  
 
 
 
2-  
 
 
 
3-  
 
 
 
4-  
 
 
 
5- 
 
 
 
6- 
 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
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UFP Code of patient________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCCL 
Number 
FDI Criteria_ _______________________________________-_____/______/______ 
A) ESTHETIC PROPERTIES 
B) FUNCTIONAL 
PROPERTIES 
C) BIOLOGICAL PROPERTIES 
1. 
Surface 
Luster 
2. 
Surface 
Staining 
3.  
Colour 
stability and 
translucency 
4.  
Fractures and 
retention 
5.  
Marginal 
Adaptation 
6. 
Postoperative 
Hipersesibility, 
tooth vitality 
7. 
Recurrence 
of Caries 
8.  
Tooth 
integrity 
(enamel 
cracks) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCCL 
Number 
USPHS Criteria______________________________________-_____/______/______ 
A) ESTHETIC PROPERTIES 
B) FUNCTIONAL 
PROPERTIES 
C) BIOLOGICAL PROPERTIES 
Surface 
Staining 
Marginal 
Discoloration 
Color 
Match 
Retention Marginal 
Integrity  
(Adaptation) 
Postoperative 
Sensitivity 
Secondary 
Caries 
Gingival 
Bleeding 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
28 
 
UFP Code of patient________ 
 
 
DENTIN SCLEROSIS CLINICAL SCALE (adapted from (32) 
Category 
 
Criteria 
 
1 
No sclerosis present; dentin is light yellowish or whitish, with little 
discoloration; dentin is opaque, with little translucency or transparency 
2 
More sclerosis than in category 1 but less than halfway between 
categories 1 and 4 
3 
Less sclerosis than in category 4 but more than halfway between 
categories 1 and 4 
4 
Significant sclerosis present; dentin is dark yellow or even discolored 
(brownish); glassy appearance, with significant translucency or 
transparency evident 
 
 
CAVITY DIMENTIONS (adapted from (16)) 
 
CAVITY 
DIMENSIONS 
(HWD)(mm) 
Height 
Width 
Depth 
Cavity dimensions in millimetres (mm) 
 
 
CAVITY  GEOMETRY CRITERIA (adapted from (16))  
 
Category 
 
Criteria evaluated by profile photograph 
 
Acute (A) 
< 45º 
Severe (S) 
45º- 90º 
Obtuse (O) 
> 90º 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
29 
 
ANNEX 3 
WORLD DENTAL FEDERATION (FDI) CRITERIA  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
30 
 
A) ESTHETIC PROPERTIES 
1. Surface Luster 
2. Staining margin 
3. Colour stability and 
translucency 
1. Clinically excellent/ very good 
1.1 Luster comparable 
to enamel 
2.1 No surface staining 
3.1 Good colour match no 
diference in shade and 
translucency. 
2. Clinically good (after correction, 
very good) 
1.2 Slightly dull, not 
noticeable from 
speaking distance. 
2.2 Minor staining, easily 
removable. 
3.2 Minor deviations 
3. Clinically sufficient/ satisfactory 
(minor shortcomings with no 
adverse effects but not adjustable 
without damage to the tooth) 
1.3 Dull surface but 
acceptable if covered 
with film of saliva. 
2.3.Moderate surface staining, also 
present on other teeth, not 
aesthetically unaccetable. 
3.3 Clear deviation but 
acceptable. Does not 
affect aesthetics: 
3.3.1.more opaque 
3.3.2.more translucent 
3.3.3 darker 
3.3.4 brighter 
4. Clinically unsatisfactory (repair 
for prophylactic reasons) 
1.4 Rough surface, 
cannot be masked by 
saliva film, simple 
polishing is not 
sufficient. Further 
intervention necessary. 
2.4 Surface staining present on the 
restoration and is unacceptable; 
major intervention necessary for 
improvement  
3.4 (Localised) clinically 
unsatisfactory but can be 
corrected by repair  
3.4.1 too opaque 
3.4.2 too translucent 
3.4.3 too dark 
3.4.4 too bright 
5. Clinically poor (replacement 
necessary) 
1.5. Quite rough, 
unacceptable plaque 
retentive surface. 
2.5 Severe staining and/or 
subsurface staining (generalized or 
localized); not accessible for 
intervention 
3.5 Unacceptable. 
Replacement necessary. 
Acceptable or not acceptable (n, %, and reasons) 
Adapted from (33)  
 
 
 
 
 
 
 
 
 
 
B) FUNCTIONAL PROPERTIES 
4. Fractures and Retention 
5. Marginal Adaptation 
1. Clinically excellent/ very good 
4.1Restoration retained, no 
fractures/cracks. 
 
5.1 
Harmonious outline, no gaps, no 
discoloration. 
2. Clinically good (after correction, 
very good) 
4.2. Small hairline crack 
 
5.2.1 Marginal gap (50 µm) 
5.2.2 Small marginal fracture removable by 
polishing. 
3. Clinically sufficient/ satisfactory 
(minor shortcomings with no adverse 
effects but not adjustable without 
damage to the tooth) 
4.3. Two or more or larger hairline cracks 
and/or chipping(not affecting the 
marginal integrity or proximal contact. 
 
5.3.1 
Gap< 150 µm not removable 
5.3.2 
Severe small enamel or dentin fractures 
4. Clinically unsatisfactory (repair 
for prophylactic reasons) 
4.4 
Chipping fractures which damage 
marginal quality or proximal contacts; 
bulk fractures with or without partial 
loss(less than half of the restoration) 
5.4.1 
Gap> 250 µm or dentine exposed 
5.4.2 
Chip fracture damaging margins  
5.4.3 
Notable enamel or dentine wall fracture 
5. Clinically poor (replacement 
necessary) 
4.5. Parcial or complete loss of restoration 
5.5 
Filling is loose but in situ. 
Acceptable or not acceptable (n, %, and reasons) 
Adapted from (33) 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
31 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
c) BIOLOGICAL PROPERTIES 
6. Postoperative 
Hipersesibility, tooth 
vitality 
7. Recurrence of Caries, 
erosion, abfraction 
8. Tooth integrity (enamel 
cracks) 
1. Clinically excellent/ very good 
6.1 
No hipersensitivity, 
normal vitality 
7.1 No secondary or primary 
caries 
8.1 Complete integrity. 
2. Clinically good (after 
correction, very good) 
6.2 
Low hipersensitivity for 
a limited period of time, 
normal vitality. 
7.2 Very small and localized 
1. Demineralization 
2. Erosion or  
3. Abfraction.  
No operative treatment 
required 
8.2.1 Small margin 
enamel(<150 µm) 
13.2.2 
Hairline crack in enamel (<150 
µm not probable) 
3. Clinically sufficient/ 
satisfactory (minor shortcomings 
with no adverse effects but not 
adjustable without damage to the 
tooth) 
6.3.1 
Premature/slightly more 
intense 
6.3.2 Delayed/weak 
sensitivity; no 
subjective complaints, 
no treatment needed. 
7.3.Larger areas of 
1.Desmineralisation 
2.Erosion 
3. Abrasion/abfraction in 
dentine  
Localized and acessible and 
can be repaired  
8.3.1 Enamel split(<250 µm) 
8.3.2 Crack        < 250 µm, no 
adverse effects. 
 
4. Clinically unsatisfactory 
(repair for prophylactic reasons) 
6.4.1 
Premature/very intense 
6.4.2 Extremely 
delayed/weak with 
subjective complaints 
6.4.3 Negative 
sensitivity intervention 
necessary but not 
replacement 
7.4.1Caries with cavitation 
7.4.2 Erosion in dentine  
7.4.3 Abrasion/abfraction in 
dentine Localized and 
accessible and can be repaired 
8.4.1 Major enamel split 
(gap>250 µm or dentine or base 
exposed) 
8.4.2 Crack>250 µm (probe 
penetrates). 
5. Clinically poor (replacement 
necessary) 
6.5 Very intense, acute 
pulpitis or no 
vital.Endodontic 
treatment is necessary 
and restoration has to 
be replaced.  
7.5 Deep secondary caries or 
exposed dentine that is not 
accessible for repair of 
restoration. 
8.5 Cusp or tooth fracture. 
Acceptable or not acceptable (n, %, and reasons) 
Adapted from (33) 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
32 
 
ANNEX 4 
USPHS (MODIFIED U.S. PUBLIC HEALTH SERVICE) CRITERIA  
Used for Clinical Evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NCT02698371 
NCCL Direct Composite Restoration Performance with Self-Etch and Multimode Adhesives Clinical Trial 
Protocol ID: FCS-UFP-2014-04-2015-07-19 
33 
RYGE´S (MODIFIED U.S. PUBLIC HEALTH SERVICE) CRITERIA FOR RESTAURATION 
EVALUATION † 
PARAMETER 
CRITERIA 
RYGE SCORE* 
ESTHETICS 
Surface Staining 
Alfa (α): No staining in the restoration and/or the tooth 
Bravo (B): Slight staining in the restoration and/or the tooth  
Charlie (χ): The staining penetrated in the restoration and/or the tooth 
in a pulpar direction 
Marginal 
Discoloration 
Alfa (α): No discoloration along the margin between the restoration and 
adjacent tooth 
Bravo (B): Slight discoloration along the margin between the restoration 
and the adjacent tooth (removable, usually localized) 
Charlie (χ): Deep staining cannot be polished away 
Color Match 
Alfa (α)*: Restoration matches the adjacent tooth structure in color and 
translucency 
Bravo (B)*: Light mismatch in color, shade or translucency between the 
restoration and the adjacent tooth 
Charlie (χ)*: The mismatch in color and translucency is outside the 
acceptable range of tooth color and translucency 
FUNCTIONAL Retention 
Alfa (α): Retained 
Bravo (B): Partially retained 
Charlie (χ): Missing 
Marginal Integrity  
(Adaptation) 
Alfa (α): No visible evidence of crevice along the margin 
Bravo (B): Visible evidence of a crevice along the margin into which 
the explorer will penetrate 
Charlie (χ): Dentin or the base is exposed 
Delta (δ)*: Restoration is fractured, mobile or missing 
BIOLOGICAL Postoperative 
Sensitivity 
A: No evidence of postoperative sensitivity  
B: Experience of postoperative sensitivity  
Secondary Caries 
A*: No evidence of caries 
B*: Evidence of caries along the margin of the restoration 
Gingival Bleeding 
A: No evidence of gingival bleeding adjacent to Class II restoration 
B: Evidence of gingival bleeding adjacent to Class II restoration 
*Alfa (α): Clinically excellent/ very good; highest degree of clinical acceptance. Bravo (B): Clinically 
satisfactory and Charlie (χ): Clinically unsatisfactory, but repairable; lower degrees of clinical acceptability. 
Delta (δ): Clinically bad, without repair; Restoration clinically unacceptable. A: No evidence of pathology 
present. B: Presence of pathology, related to restoration.  
† Source: Adapted from (34)