Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients :A Randomized Clinical Trial
Phase: NA
Conditions: Class V Dental Caries, High Caries Risk Patients
Sponsor: Cairo University

 
 
 
CLINICAL EVALUATION OF THREE DIFFERENT BIOACTIVE 
RESTORATIVE MATERIALS IN CERVICAL CARIOUS 
LESIONS IN HIGH CARIES RISK PATIENTS:  
A Randomized Controlled Clinical Trial 
 
 
 
 
 
 
Protocol submitted to 
Faculty of Dentistry, Cairo University  
for partial fulfillment of the requirements for the PhD Degree in Restorative and 
Esthetic Dentistry. 
 
By 
 
Ahmed Abdul Monsif Abdul Mohsen Abdul Aziz 
ID: 14422022532609 
Theme .Objective code: CONS 3.7.5 
BDS 2011, Faculty of Dentistry, MUST University 
MSc. 2019, Faculty of Dentistry, Al-Azhar University 
2024 
 
                                                    Code: CONS 3.7.5  
 
       Supervisors’ signature                                                    Head of department’s signature  
1- 
 
2- 
 
 
                  Date                            
 
 
 
 
 

II 
 
Protocol checklist 
 
 
 
 
Section and topic 
 
 
 
 
Item no. 
 
 
 
 
Checked item 
 
 
 
 
Reported 
on page 
No. 
 
 
 
 
Reviewer’s check
 
 
 
I. Administrative information  
 
 
1 
Title  
 
 
2 
Protocol registration  
 
 
3 
Protocol version  
 
 
4 
Funding  
 
 
5 
Roles and responsibilities  
 
 
 
II. Introduction  
 
 
 
 
A) Background and Rationale  
 
6 a 
 
Research question  
 
 
Statement of the problem  
 
 
Rationale for carrying out the trial  
 
 
Review of literature  
 
 
6 b 
Choice of comparators  
 
 
 
B) Objectives  
7 
 
Aim of the study  
 
 
Hypothesis  
 
 
C) Trial design  
8 
Trial design  
 
 
 
III. Methods  
 
 
 
 
A) Participants, interventions & 
outcomes  
 
9 
Study setting  
 
 
10 
Eligibility criteria  
 
 
11 
Interventions  
 
 
12 
Outcomes  
 
 
13 
Participant timeline  
 
 
14 
Sample size  
 
 
15 
Recruitment  
 
 
 
 
 
 
16 
Allocation  
 
 
16 a 
Random sequence generation  
(Randomization)  
 
 

III 
 
B) Assignment of interventions  
16 b 
Allocation concealment mechanism   
 
16 c 
Implementation  
 
 
17 
Blinding (masking)  
 
 
C) Data collection, management, 
and analysis  
 
18 
Data collection methods  
 
 
19 
Data management  
 
 
20 
Statistical methods  
 
 
 
D) Monitoring  
 
21 
Data monitoring  
 
 
22 
Harms  
 
 
23 
Auditing  
 
 
 
 
 
 
 
IV. Ethics and dissemination  
 
 
24 
Research ethics approval  
 
 
25 
Protocol amendments  
 
 
26 
Informed Consent  
 
 
27 
Confidentiality  
 
 
28 
Declaration of interests  
 
 
29 
Access to data  
 
 
30 
Ancillary and post-trial care  
 
 
31 
Dissemination policy  
 
 
 
V. Estimated research budget  
32 
 
 
 
 
V. Appendices  
 
33 
Informed consent materials  
 
 
 
34 
Biological specimens  
 
 
 
VI. Statement of originality  
3 
Statement of originality  
 
 
VII. References  
 
 
 
 
 
Scientific committee  
 
Primary reviewer 
Signature 
Date 
1. 
 
 
Secondary reviewers 
Signature 
Date 
1. Prof. Elham Fawzi 
 
 
2. Prof. Asmaa Yassin 
 
 
3. Dr. Omar Shaalan 
 
 
 
 
 
 
 

IV 
 
 
 
 
 
 Administrative information: 
 
1. Title: 
Clinical evaluation of three different bioactive restorative materials in cervical carious lesions 
in high caries risk patients: A Randomized Controlled Clinical Trial. 
2. Protocol registration:  
Clinicaltrials.gov ID: The trial will be registered in clinical trial.gov 
3. Protocol version:  
First version September 2024  
4. Funding:  
Self-funding  
5. Roles and responsibilities:  
i. 
Ahmed Abdul monsif Abdul Mohsen Abdul aziz (A.A) 
 Operator, data entry and corresponding author: BDS; 2011 Misr University for science and 
technology, MSc; 2019 Al-Azhar University, Egypt. 
 ahmed.monsif@dentistry.cu.edu.eg 
ii. 
Dr. Ashraf Nasr (A.N)  
Main supervisor, data monitoring and auditing. Professor of Conservative Dentistry, Faculty of 
Dentistry, Cairo University, Egypt. 
 ashraf.nasr@dentistry.cu.edu.eg 
iii. 
Dr. Yehia Hafez (Y.H)  
Co-supervisor, data entry and auditing, data collection. Lecturer, Conservative Dentistry 
Department, Faculty of Dentistry, Cairo University, Egypt.  
yehiahafez@dentistry.cu.edu.eg 
iv. 
Evidence based dentistry committee (EBD)  
Reviewing study protocol following SPIRIT guidelines; Faculty of Dentistry, Cairo University, 
Egypt. 
 
 

V 
 
 
 
v. 
Research Ethics Committee (REC)  
Reviewing of the clinical trial in order to protect the right, safety, dignity and wellbeing of the 
participants; Faculty of Dentistry, Cairo University, Egypt. 
vi. 
Medical biostatistics unit (MBU)  
Reviewing calculated sample size.  
vii. 
Trial sponsor (Cairo University)  
Tel: (+202) 23634965 / (+202) 23642938 
 - Fax: (+202) 23646375 
 - Address: 11 El Saraya St.-Manial, Cairo.  
- Official mail: dentmail@dentistry.cu.edu.eg 
 
 
 
 

1 
 
 Introduction:  
 
6 a) scientific background 
 
Dental caries or tooth decay is considered a complex and polymicrobial dysbiosis, resulting from 
an imbalance in the demineralization and remineralization process. Class V defects are presented by 
pathological loss of enamel or dentin at the cervical line either related or not related to bacterial attack 
Mira et al. (2015). 
The risk factor of cervical caries includes physical, biological, environmental, behavioral, and 
lifestyle-related condition such as high numbers of cariogenic bacteria, inadequate salivary flow, 
insufficient fluoride exposure, carbohydrate rich diet, poor oral hygiene. Additionally, occlusal loading 
forces during function and parafunction, create stress concentration in the cervical region, thus become 
a cofactor in the etiology and progression of cervical teeth caries Roberts et al. (2022). 
Restoration of class V is often complicated by many factors; as the lack of sufficient enamel tissue, 
dentinal sclerosis, sensitivity, esthetics challenges, size of the cavity, cavity preparation technique, 
moisture contamination, patient age and restorative material Pecie et al. (2011). 
Previously the restorative materials were recommended to be passive, without any interactions with 
the surrounding environment. However, it was recommended later that these materials should have 
useful effect on the dental tissues. This initiated the first sparks to produce active materials, with definite 
interactions with the human body and fluids which were prompted by the concept of fluoride-releasing, 
McCabe et al. (2011). 
Glass ionomer cement (GIC) is the adhesive restorative material with several other favorable 
properties including biocompatibility, ﬂuoride release and a coeﬃcient of thermal expansion compatible 
with tooth tissues. However, they lack the ideal ﬂexural strength and wear resistance to perform 
satisfactorily in class V lesions Mickenautsch et al. (2011). 
 
The “smart materials” term is applied to material that can be altered in a controlled fashion by stimuli, 
such as pH, stress, temperature, moisture and can return to the original state after the stimulus removal. 
This material imitates nature and participates in this dynamic ionic exchange as responding to change 
in oral environment Opdam et al. (2014). It is water-based or has the capacity for significant water 
transport or storage. It can continuously release and recharge their ionic components with physical 
properties such as resin composite with release and recharge of calcium, phosphate, and fluoride similar 
to glass ionomers, Bansal et al. (2016).  
Bioactive restorative materials are relatively new concept in dentistry combines between esthetics, 
strength and resilience of composites with bioactive properties, the development of therapeutic bio-
interactive materials results in tissue re-mineralization, reduces the susceptibility to tooth mineral loss, 
and recovers its mechanical properties Sonarkare et al. (2015). 

2 
 
 Their ability to release ions is most frequently associated with increased resistance of dental tissue 
to acid attack like calcium, phosphate and fluorides, which may come from the saliva or external sources. 
Calcium phosphate in the saliva is the natural defense against mineral loss from the tooth also fluoride 
is considered additional methods of controlling the demineralization and re-mineralization process 
Andreia et al. (2020). 
 
 Research question: 
Will the three different bioactive restorative materials have the same clinical performance in 
cervical carious lesions in high caries risk patients over eighteen months of follow-up ? 
 
 Statement of the problem:  
Class V defects are presented by the pathological loss of enamel and /or dentin at the cervical line 
either related or unrelated to bacterial attack, the carious lesions are due to an infectious process caused 
by acids from bacterial metabolism diffused into enamel and dentin and dissolved the mineral. 
Therefore, the management and handling of these defects have gained more importance as its one of the 
dominate problems that faced clinical practitioners Dietschi et al. (2011). 
Patients, with high caries, have many risk factors like inadequate biofilm control, salivary flow 
deficiency, and altered host defense. Conventional restorative materials expose the tooth structure to 
stress concentration. Moreover, preserving the tooth restoration interface intact is great challenge to 
avoid recurrent caries, which may also result in restoration failures Françoise et al. (2014). 
 Cervical lesions restorations are posing a challenge to the dental profession, adhesive failure is 
often attributed to inadequate moisture control, adhesion to different substrates (enamel and dentin), 
differences in dentin composition, and great flexural stresses acting on the restoration that may lead to 
early loss or fracture Cesar et al. (2012). The mechanical stresses are created in the resin composite as 
a result of the contraction, breaking the marginal seal between the composite resin and the dentin or 
enamel Al-gailani et al. (2019). Predominant modes of failure for class V restorations includes loss of 
retention originate partial or complete loss of restoration and secondary caries Stewardson et al. (2012).  
So, recent advancements in dental restorative materials represent a new biomaterial with physical, 
mechanical and biological properties like biocompatibility, aesthetics led to the era of many different 
types of dental restorations Darvell et al. (2022). 
 
 
 
 

3 
 
 Rationale:  
Conservative treatment aims to replace missing dental tissue to help control plaque, restore tooth 
function and protect the pulp-dentinal complex by sealing the cavity produced after caries removal, the 
ideal material for the restoration of decayed teeth should have these properties: biocompatibility, 
bioactivity, aesthetics, handling, radio opacity and short processing times Innes et al. (2016). 
The ionic resin component of one of interventions in this study contains phosphate acid groups with 
antimicrobial properties that improve the interaction between the resin and the reactive glass fillers with 
polyacid components of glass ionomer, which undergo the acid-base setting reaction, they are also 
formulated with a bioactive ionic resin matrix, also has shock-absorbing resin component. Bioactive 
fillers mimic the physical and chemical properties of teeth. Bhadra et al. (2019). 
On other hand dual cure ability of the another intervention has been recommended as they allow to 
bulk fill the foundation restorations with adequate working and setting time, while reducing the effect 
of light attenuation on the depth of cure due to the effect of continued chemical curing after photo 
activation Vandewalker et al. (2016). 
 External validity: 
In spite of the advantages and current enhancements within composite resin for dental requirements, 
an ambition for the improvement of substitute, bioactive restorative materials are perceived. These 
materials deliver minerals that are valuable to the tooth structure that stimulate re-mineralization process 
Jefferies et al. (2015). 
Dual-cure bioactive material enables the dentist to fill the cavity in one increment, no matter how 
large the restoration. That saves time and minimizes the shrinkage tension in the tooth restoration 
interface. Being able to bulk fill in a single increment also minimizes the risk of contamination, as the 
whole procedure can be done much more quickly and efficiently Thadathil et al. (2023).  
 Moreover bioactive materials are a dynamic, moisture-friendly, mineral-enriched composite which 
emits and recharges fluoride, calcium and phosphate, providing teeth with the minerals they require to 
stay healthy. Bioactive restorations indicated in high-risk caries patients as they inhibit cariogenic 
bacteria that cause demineralization at the tooth-restoration interface. They also provide good sealing to 
cavity walls, while in addition providing continuous fluoride, calcium and phosphate ion release and 
uptake by enamel overcoming the problems faced in glass ionomer restorations Czasch et al. (2013). 
 
 
 
 
 

4 
 
 Review of literature: 
Developing a suitable dental material is challenging as restorative dentistry becomes less invasive 
and more bioactive,  innovation is incorporating bioactive components to improve the tooth-filling bond, 
along with the traditional adhesion, through forming and integrating hydroxy apatite crystals within the 
dentinal tubules, thereby reducing the odds of marginal leakage and further secondary caries formation. 
In addition, the remineralisation potential of affected hard dental tissue may be beneficial in children 
with high caries experience De Caluwe T et al. (2017). 
Such a restorative material as ACTIVA might provide a reliable alternative treatment to the 
traditional restorative procedure with improved mechanical properties, bioactivity, ability to release 
fluoride, and the possibility of placement in 4–5 mm increments. 
However, up to date, there is scarce information in the literature about this restorative material, and 
there needs to be more reliable in vivo studies with long follow-up periods 
Tests that evaluated biocompatibility and bioactivity of the restorative material: 
 G Conti et al. (2023) Evaluation of Antibacterial Activity of a Bioactive Restorative Material 
versus a Glass-Ionomer on Streptococcus Mutans: In-Vitro Study. 
Each material was formed into disks of 4 mm in diameter, and four discs of each material were 
placed on nine agar plates. The analysis was repeated seven times. Both materials showed statistically 
significant growth inhibition properties against S.mutans . The difference in the effectiveness of the two 
materials was not statistically significant. Conclusion: Both ACTIVA™ and Ketac™ Silver can be 
recommended since both are similarly effective against S. mutans. However ACTIVA™, given its 
bioactivity and better aesthetics and mechanical properties compared to GICs, may provide better 
clinical performance. 
 They found that using of both ACTIVA™ and Ketac™ Silver can be recommended in pediatric 
dentistry clinical practice, especially in patients at high risk for developing secondary caries; however, 
considering its pronounced bioactivity and better aesthetic and mechanical properties compared to 
GICs, ACTIVA™ might provide higher clinical performance and hence be overall the more valid 
option. 
 
Shara I et al. (2021) assess the remineralisation potential of Activa BioActive-Restorative and 
Beautifil II restoration on demineralised dentine samples, and compares it with glass-ionomer (GIC) 
restoration using energy dispersive X-ray (EDX) and Knoop hardness number (KHN) by using Non-
carious extracted molar teeth , number of ten teeth were sectioned into halves and partially 
demineralised using 37.0% phosphoric acid for 60 s. All samples are assessed using EDX and KHN 
prior to restorations. The samples are then subdivided into four groups. Group 1 was restored with 
Activa BioActive-Restorative, Group 2 received Beautifil II, Group 3 was restored with GIC, and the 
last group was used as a negative control. Assessment of remineralisation potentials of bioactive dental 

5 
 
composite using an in-vitro demineralised dentine model. They conclude that Activa BioActive-
Restorative restoration presents superior remineralisation compared to Beautifil II and glass-
ionomer dental restorations. 
 
Wannakorn S et al. (2023) a compare the remineralization of initial interproximal carious lesions 
adjacent to Predicta Bioactive Bulkfill composite and conventional resin composite by analyzing the 
percentage of surface microhardness recovery. Sixteen human enamel specimens were assigned into two 
groups Group 1 (Predicta Bioactive Bulk-fill composite) and Group 2 (Resin composite Filtek Z350). 
The baseline surface microhardness was determined using a Knoop surface microhardness assay. 
Artificial enamel carious lesions were created and then, surface microhardness was recorded 
postartificial carious lesions formation. After that, interproximal contacts were stimulated by putting 
these enamel specimens in contact with class II restorative materials.  
All samples in each group underwent a pH cycling process for 14 days and post-pH cycling surface 
microhardness was assessed. A dependent t-test was used to compare the surface microhardness between 
baseline and post-artificial carious lesions formation within each group, and between post-artificial 
carious lesions formation and post pH-cycling within each group. There was significant difference in 
the mean percentage of surface microhardness recovery between group 1 and group 2 with a 
significance. Predicta Bioactive Bulk-fill composite markedly increased the surface microhardness of 
adjacent initial interproximal carious lesions compared with resin composite Filtek Z350 restorations. 
Therefore, Predicta Bioactive Bulk-fill composite could be an alternative restorative material to 
remineralize initial enamel carious lesions in a proximal adjacent surfaces. 
Tests that evaluated clinical performance of the restorative materials: 
Shelan S et al. (2021) examine Immediate and long term gingival marginal leakage of two bioactive 
restorative materials in class II cavity preparations. Using Forty eight maxillary first premolar teeth of 
comparable sizes were collected and allocated into three main groups according to the restorative 
materials used: Group (A): Filtek™ Bulk Fill, Group (B): Predicta bulk bioactive composite, Group (C): 
ACTIVA bioactive composite. Two slot cavities, with standardized dimensions, were prepared in each 
tooth (3mm buccolingual, 2mm mesiodistal, and mesial gingival margin located 1mm coronal to CEJ 
and distal gingival margin located 1mm apical to CEJ.  
The restored samples were thermo-cycled and then immersed in methylene blue dye (2%) for 24 
hours. Dye diffusion was evaluated by inspect the sectioned samples using digital microscope at 40× 
magnification ,The results showed statistically insignificant differences among the restorative materials 
at 24 hours. However, after 90 days storage the differences were statistically significant Predicta™ 
showed lowest microleakage followed by Filtek™ bulk fill while ACTIVA™ showed the highest 
microleakage. 
 

6 
 
Talat M et al. (2018) evaluate the bioactive resin modified GIC material (Activa) vs. conventional 
one (Vitremer) clinically and laboratory. Clinically by Fifteen healthy children of both sexes aged (4-7) 
having a bilateral similar initial occlusal caries on the lower 2nd primary molars were selected. A split-
mouth design was used where conventional Class I cavities were prepared on carious molars. One side 
was restored with Activa and the contra-lateral side restored with Vitremer (control).  
The patients were recalled for clinical evaluation at 3, 6 and 12 months postoperative. The modified 
United States Public Health Service (USPHS) evaluation criteria were used. Laboratory included: 1. 
Mechanical strength tests (compressive and diametral tensile). 2. Shear bond strength test between both 
restorative materials and dentin. They found clinically: The overall clinical outcome showed no 
significant difference between both groups in all evaluated criteria. Laboratory: Activa showed higher 
values than Vitremer in all tested groups and the differences were significant. 
Reda B et al. (2023) Two-year clinical and radiographic evaluation of ACTIVA BioACTIVE 
versus Compomer (Dyract® eXtra) in the restoration of class-2 cavities A split-mouth design was 
considered. A pre-calculated sample size of 96 molars (48 per group) with class-2 cavities. Pre-operative 
Plaque Index (PI), DMFT/dmft scores and the time required to fill the cavity were recorded. Over 24 
months, the teeth were clinically evaluated every six months and radiographically every 12 months by 
two calibrated and blinded evaluators using the United States public health service (USPHS)-Ryge 
criteria. They found the performance of ACTIVA was not inferior to Dyract and both materials had a 
comparable high clinical and radiographic performance in children with high-caries experience. 
ACTIVA had a significantly better color match but more marginal discoloration. It took significantly 
less time to be placed in the oral cavity. 
Mona M et al. (2021) evaluate the clinical performance of a bioactive restorative material vs a glass 
hybrid restorative material in posterior restorations in high caries risk patients. High-risk caries patients 
with multiple posterior cavitated caries lesions were enrolled in this split-mouth clinical trial. Fifty 
randomly selected teeth received either a resin-modified glass ionomer bioactive resin-based composite, 
BioACTIVE-RESTORATIVE (Activa)] or a bulk-fill glass hybrid restorative [EQUIA Forte Fil 
(Equia)]. Two well-trained experienced blinded assessors evaluated the restorations at baseline, 6, and 
12 months using FDI criteria for direct and indirect restorations. The survival percentages for the 
intervention and comparator groups were 98% after 6 and 12 months.  
Regarding the primary outcome, no statistically significant difference was observed between the 
two groups. While for the secondary outcome, the color match parameter showed a significantly better 
score for Activa at baseline, 6, and 12 months. With respect to the anatomic form, Activa scored 
significantly better compared to Equia at 6 and 12 months .Regarding functional properties, at baseline, 
no difference between the tested groups was observed for all functional parameters .  
Furthermore, at 6 and 12 months, Activa scored significantly better for occlusal contour and wear 
compared to Equia. So, they conclude that Both ACTIVA™ BioACTIVE-RESTORATIVE™ and 
EQUIA Forte Fil showed similar successful clinical performance while restoring permanent posterior 

7 
 
teeth in high-risk caries patients. The use of EQUIA Forte Fil may be more appropriate as a semi-
permanent restorative material in stress-bearing restorations.  
With respect to the esthetics of upper premolars, ACTIVA™ BioACTIVE RESTORATIVE™ 
exhibited superior esthetics. Clinical significance: ACTIVA™ BioACTIVE-RESTORATIVE™ may be 
used to restore permanent posterior teeth in high-risk caries patients offering enhanced esthetics and 
wear resistance. 
6 b) Choice of the comparator: 
Pre-reacted glass ionomer (PRG) technology restorative materials introduced from more than 15 
years ago, and they contain pre-reacted glass ionomer (PRG) filler particles embedded in a resin matrix. 
They manufactured by reacting acid-reactive fluoride-containing glass with polyacids in the presence of 
water.  PRG fillers are divided into two categories: full reaction type PRG (F-PRG) fillers and surface 
reaction type PRG (S-PRG) fillers. In F-PRG fillers, the entire filler particle reacts with polyacrylic acid 
and releases a large amount of fluoride as the core of the particle is completely reacted Yadav et al. 
(2012). 
     The technology offer improvement in clinical handling and physical characteristics compared with 
conventional and resin-modified glass ionomers while providing the esthetic properties of resin 
composites.  S-PRG fillers in Pre-reacted glass ionomer materials also allow for the release and recharge 
of fluoride that is comparable to glass ionomer materials but is more than that of fluoride-containing 
resin composites Naoum et al. (2011). 
The main advantages of pre-reacted glass ionomer (PRG) material that releases calcium, phosphate and 
fluoride ions to stimulate mineral apatite formation and re-mineralization at the material-tooth interface. Delivers a 
unique combination of physical and chemical properties. It is dimensionally stable, with excellent strength, time-
efficient handling, and physical properties similar to those of natural dentin Montoya et al. (2022). In addition 
to aesthetic, and highly radiopaque material that is approved for all types of cavities and load - carrying 
applications, forms a surface layer of an appetite-like material in the presence of an inorganic phosphate 
solution Chen et al. (2013). 
The Bioactive Functions of pre-reacted glass ionomer material that tooth strengthening as S-PRG 
filler contributes to strengthening tooth structure by Promote mineralization and re-mineralization of 
teeth. Acid Neutralization as It helps neutralize acids produced by bacteria. So, reducing the risk of tooth 
decay. And released ions inhibit microbial growth. Also, S-PRG helps prevent degradation of tooth 
structure by Matrix Metalloproteinase Inhibition, Satoshi et al. (2023). 
     
     This prospective study will be investigating and comparing the eighteen month clinical performance 
of a different bioactive restorative materials and a conventional Pre-reacted glass ionomer restorative 
material in class V cavity preparation. 
 

8 
 
7. Objectives 
 
 Aim of the study: 
The aim of the study is to clinically evaluate three different bioactive restorative material in cervical 
carious lesion in high caries risk patients.    
Reducing the incidence of recurrent caries is the primary outcome. 
 
 Hypothesis:  
Null hypothesis: There is no differences between three bioactive restorative materials in carious 
cervical cavities at different follow-up periods (baseline, 6, 12 and 18) months. 
 
8. Trial design:  
- The study design in this investigation will be a randomized clinical trial design.  
- The design for this randomized clinical trial is a superiority framework with parallel groups with 
equal allocation ratio. 
 
 
 
 
 
 
 
 
 
 
 

9 
 
  Methods  
A) Participants, interventions & outcomes  
9. Study settings: 
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo 
University outpatient clinic. The operator in charge will be Ahmed Abdul monsif Abdul mohsin. 
The researcher will bear ultimate responsibility for all activities associated with the conduct of a 
research project including explaining and performing the procedures to the patients. 
10. Eligibility criteria: 
The patients in this study will be selected according to different exclusion and inclusion criteria. 
The inclusion criteria : patient age range from 25-45 year, high risk caries , patients required at least 
a couple of Class V restorations , the depth of lesion should be(1.5- 2mm) .The patient should have 
good general health . 
Where the exclusion criteria will be: poor oral hygiene, sever or chronic periodontal disease or 
bruxism, severe tooth sensitivity, non-vital or fracture or cracked teeth, defective restorations, 
orthodontic treatment or bleaching procedures during the last 6 months, pregnancy, and/or lactation, 
and allergy to the main components of the products to be used in the study. 
 After the selection of patients according to inclusions and exclusions criteria, Patients will given 
oral hygiene instructions before operative treatments and receive dental prophylaxis 1 week before 
the procedures. 
11. Interventions 
The teeth will be randomly allocated to the three experimental groups according to the tested 
materials as follows: (Group 1) restored with dual cure bulk fill bioactive restoration Predicta™, 
(Group 2) restored with Activa™ bioactive restorative and (Group 3) restored with Pre-reacted glass 
ionomer (PRG) Giomer. Will used to restore these cavities. 
Clinical Procedures: 
 Local anesthesia will be applied when necessary. The operating field will be isolated using 
Hygienic clamp no. (206, 2A, W2) and rubber dam. 
The box-shaped class V cavities will be prepared using Tungsten carbide fissure bur #330, SS 
(Lakewood, NJ, USA) held in high speed contra-angled hand piece with water cooling. All internal 
line angles will be slightly rounded and bevel at the cavo-surface of the occlusal wall with flame 
shaped diamond bur, each bur will discarded after 5 cavities preparations to maintain cutting 
efficiency Yazici A et al. (2003). In case of presence of deep carious spots, they will be removed 

10 
 
with a spoon excavator and/ or large round bur at slow speed. A thin layer of calcium hydroxide 
liner will be placed in all deep spots then etched with 37% phosphoric acid. 
  Restoration procedure:  
All restorative materials will be applied according to the respective manufacturer’s instructions. 
Group 1: restored with Predicta™, cavity bonded using Scotchbond single-component universal 
Adhesive, (3M ESPE, USA), injection of restoration through Double-bleed cartridge into the cavity, 
To minimize shrinkage stress, allow the material to self-cure for 1-2 minutes before light curing, 
then light-cured 20 seconds. 
Group 2: restored with Activa™ ,Cavities will be bonded using Scotchbond single-component 
universal Adhesive, (3M ESPE, USA),the restoration will be applied through a 19-gauge applicator 
tip on the syringe and apply in 2mm increments, light curing for 20 seconds between each layer. 
Group 3: restored with Giomer, Cavities will be bonded using BeautiBond Xtreme Universal light 
cure adhesive, The material will be applied using a plastic instrument and then light-cured for 10 s 
for each layer using an LED light cure unit.  
 Finishing will performed for each restoration by just removing any excess restorative material 
surrounding the cervical matrix using a scalpel before the step of final light curing of restorations, 
with no need for further finishing and polishing. 
 
Material 
 
Specification 
 
Ingredient 
 
Manufacturer 
 
Activa 
presto 
Bioglass 
reinforced 
glass 
ionomer 
Blend of diurethane and other methacrylates with 
modified polyacrylic acid. 55.4 wt% Bioactive 
glass and sodium fluoride 
 
Pulpdent Co. 
Oakland, MA, 
USA 
 
Predicta 
 
Dual-cure 
Bulk Fill 
composite 
Calcium, phosphate, nano-hydroxyapatite, 2-
Propenoic acid, 2-methyl-, (1-
methylethylidene)bis[4,1phenyleneoxy(2-hydroxy-
3,1-propanediyl)] ester, dibenzoyl peroxide 
 
Parkell Inc. 
Edgewood, 
NY, USA 
 
 
Beautifil II 
LS  
 
 
Giomer II 
Glass powder, Urethan diacrylate, Bis-MPEPP, 
Bis-GMA, TEGDMA, Polymerization initiator, 
pigments and prereacting a fluoro-aluminosilicate 
glass filler with polyacrylic acid. 
 
 
SHOFU Inc. 
Kyoto, Japan 
BeautiBond  
Xtreme 
Universal 
light cure 
adhesive 
Acetone, Bis-GMA, TEGDMA, Phosphonic acid 
Monomer Carboxylic acid monomer Water. 
HEMA free 
 
SHOFU Inc. 
Kyoto, Japan 
 
Scotchbond 
Universal 
light cure 
adhesive 
MDP Phosphate Monomer, Ethanol, 
Dimethacrylate resins, HEMA, Vitrebond™ 
Copolymer, Filler, Silane, Water. 
 
3M, ESPE 
USA 
 

11 
 
 
  Clinical evaluation:  
All restorations will be subjected to a clinical follow-up schedule according to the outcome: 
Primary outcome (post-operative hypersensitivity): through three follow-up periods (after 24 hours 
(baseline), 6 months, 12 months). 
Secondary outcome: representing four follow-up periods (after 24 hours (baseline), 6 months , 12 
months and 18 months) during which, two examiners not involved in the placement of the 
restorations will calibrated to evaluate the restorations according to the modified United States 
Public Health Service (USPHS) criteria for retention, marginal adaptation, marginal discoloration, 
secondary caries, anatomical form, surface texture, and color matching(15) . The restorations will 
be scored as Alfa (A): The ideal clinical situation, Bravo (B): Clinically acceptable or Charlie (C): 
Clinically unacceptable. 
Evaluation will be carried out under a dental operating light, using flat surfaced mouth mirrors, 
dental explorers and direct vision with the aid of an intraoral camera. In addition digital photographs 
will be taken using digital camera for future reference and documentation.  
The variations for some characteristics at various recall examinations need to be interpreted with 
caution. To facilitate the uniformity among examiners, it will be important to seek the help of inter-
examiner calibration/rating. Thus a 3rd examiner has to be ready whenever there is any confusion 
between Alpha & Bravo scoring rated by the 2 examiners, to decide the final rate. 
 
  Instruction given to the patient:  
All participants will be instructed to follow oral hygiene measures (brush the teeth modified bass 
technique twice a day, floss once a day, consider a mouthwash) to avoid plaque and bacterial 
accumulation which may negatively affect the clinical performance in regards to micro-leakage or 
loss of retention. 
  Statistical Analysis 
 The collected data along all the evaluation periods will be collected, tabulated and statistically 
analyzed using software statistical package for social science (SPSS) version 20, computer program. 
Chi-Square test will performed to investigate the descriptive data of each criterion separately. 
 
 
 
 

12 
 
12. Outcomes: 
  None of the restorations had shown any secondary caries and anatomic form loss until the end of 
18 months is the primary outcome. The outcome data collected directly from participants and 
analysis by Modified USPHS criteria measurement.  
The tested criteria (postoperative hypersensitivity, restoration retention, marginal adaptation, 
marginal seal, marginal discoloration, secondary caries, anatomical form, surface texture and 
color matching) will be evaluated according to the modified USPHS criteria.  
Prioritization of 
Outcome 
Outcome 
Follow 
up 
Method of 
Measurement 
(with reference) 
Unit of 
Measurement 
 
 
1ry outcome  
 
 
 
Post-operative hyper 
sensitivity. 
 
 
12 
months 
Modified USPHS 
criteria 
measurement 
Bayne S. et al. 
(2005) 
 
 
Binary  
(yes/ no) 
 
 
2ry outcomes  
 
Fracture and retention, 
marginal integrity, marginal 
discoloration, anatomic 
form, surface texture, 
postoperative sensitivity. 
 
 
18 
months 
 
Modified USPHS 
criteria 
measurement 
Bayne S. et al. 
(2005) 
 
 
Ordinal data 
Categorical 
(scores) 
 
Modified United States Public Health Service Criteria (USPHS): 
Characteristic 
Evaluation criteria 
Retention 
Alfa: the restoration is present 
 Charlie: the restoration is absent 
 
Anatomical form 
Alfa: restoration is continuous with existing anatomic form.  
Bravo: restoration is discontinuous with existing anatomic form, but 
missing material is not sufficient to expose dentin or base.  
Charlie: sufficient material is lost to expose dentin or base. 
 
 
 
Marginal 
adaptation 
Alfa: restoration is closely adapted to the tooth. The explorer does not 
catch when drawn across the surface of the restoration toward the tooth 
structure, or if the explorer does catch, there is no visible crevice along the 
periphery of the restoration.  
Bravo: the explorer catches and there is visible evidence of a crevice, 
which the explorer penetrates, indicating that the edge of the restoration 
does not adapt closely to the tooth structure. The dentin and/or the base are 
not exposed and the restoration is not mobile.  
Charlie: the explorer penetrates a crevice defect that extends to the dentin-
enamel junction 

13 
 
 
 
 
 
Marginal staining 
Alfa: there is no visual evidence of marginal discoloration different from 
the color of the restorative material and from the color of the adjacent tooth 
structure.  
Bravo: there is visual evidence of marginal discoloration at the junction of 
the tooth structure and the restoration that has not penetrated along the 
restoration in a pulpal direction.  
Charlie: there is visual evidence of marginal discoloration at the junction 
of the tooth structure and the restoration, but the discoloration has 
penetrated along the restoration in a pulpal direction. 
 
 
 
Surface texture 
Alfa: surface texture is similar to polished enamel as determined by 
means of a sharp explorer.  
Bravo: surface texture is gritty, similar to a surface subject to a white 
stone, or rougher than the adjacent tooth structure.  
Charlie: surface pitting is sufficiently coarse to inhibit the continuous 
movement of an explorer across the surface 
 
Secondary caries 
Alfa: no caries is present. 
 Charlie: caries is present. 
 
Participant timeline: 
 
Time point 
Enrolment 
Allocation 
T0  
T1 
6months 
T2 
12months 
T3 
18monsths 
Eligibility screen 
√ 
 
 
 
 
Informed consent 
√ 
 
 
 
 
Clinical exam 
√ 
 
 
 
 
Allocation 
 
√ 
 
 
 
Diagnosis and 
treatment decision 
 
 
 
 
 
Visual inspection 
 
 
√ 
√ 
√ 
 
13. Sample size: 
The sample size was calculated based on a previous study by Nahar et al. (2021), in which 
percentage of post-operative hypersensitivity of Giomer in cervical restorations 97.5%. By 
implementing a two tailed Z test for difference between two independent proportions with an 
alpha level of 5% and a power of 80%. The minimum sample size needed was 24 per group in 
order to detect a difference of 30%. Sample size was increased by 10% to compensate for possible 
dropouts to reach 27 teeth per group. Sample size was performed using G*Power version 3.1.9.2 
for windows 

14 
 
14. Recruitment and Recruitment Strategy: 
Screening of patients that come to the Conservative Dentistry Department seeking dental care will 
continue until the target population is achieved. The patients will be subjected to examination and 
diagnosis. Once the patients that are potentially eligible for this study are identified, the research 
operator who will explain the study and ascertains the patient’s interest will contact them. 
 
Then the patient will sign the informed consent to ensure the approval for all the prosecuted that 
will be done and his/her acceptance to participate in this trial.  
 
 Assignment of Interventions: 
 
15. Allocation:  
 
15a. Randomization:  
 
Randomization will be done using simple randomization by computerized sequence generation 
using www.random.org by generating numbers from 1:30 into three columns. 
 
      15b. Allocation concealment mechanism:  
 
The randomization list will be kept and secured away to ensure no tampering with the random list. 
Each participant will choose a random number from an opaque sealed envelope. When the 
participant chooses an envelope, it will be signed and the supervisor and the number on the envelope 
will be recorded in the patient chart to ensure that the patient is assigned to the randomized group. 
 
     15c. Implementation:  
Will generate the random allocation sequence, enroll the patients and will assign the 
interventions/comparator identification procedures to respective teeth. 
16. Blinding 
The assessor who will evaluate the outcomes will be blind to the participants’ allocation group, 
and the statistician will be blinded. 
 
 
 
 
 
 

15 
 
 Data collection, management, and analysis 
17. Data collection methods: 
The follow-up assessments will be performed by a pre-calibrated examiner, who does not have 
previous contact with the patient and with last information about the allocation groups and 
treatments performed. The treatment needs will be established according to the demands of the 
patients. 
 
18. . Data management: 
The clinical data will be registered on sheets previously organized on Microsoft Excel Software. 
All data, except those that might reveal the participants’ identities, will be shared in a public 
repository after accepting all manuscripts related to these studies. Backup of data will be saved on 
an external hard disc to prevent data loss. 
 
19. Statistical methods: 
Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), 
version 26 (SPSS Inc., Chicago, IL). Categorical data will be described as frequency (n) and 
percentage (%). Comparisons between categorical variables will be performed using the chi square 
test. A p-value less than or equal to 0.05 will be considered statistically significant and all tests will 
be two tailed. Statistical power of the study will be set at 80 % with 95 % confidence level. 
 
The calculation of sensitivity, specificity, and accuracy will consider the results obtained with the 
indices and the classification of the presence or not of caries lesion by the proposed reference 
standard. As also, for the comparisons between the treatment decisions obtained with the different 
criteria. The cost-effectiveness ratio will also be verified, considering as effect the prevention of the 
primary outcome, as well as other secondary endpoints of interest, and the cost spent to reach such 
a condition with each of the indices.  
 Monitoring:                                                               
20. Data monitoring 
Independent regulation of data collection, management, and analysis will be assumed independently 
by main supervisor (A.N). His role is to monitor any risk of bias could be done from participants, 
operator or assessors. 
21. Harms     
The procedures performed offer minimal risk to the oral health of patients. The adverse effects are 
represented by the teeth with pain episodes, postoperative sensitivity, and tooth fracture during the 
restorative procedure, teeth requiring endodontic treatment, and exodontia. In dental treatment, the 

16 
 
possibility of occurrence of these effects is usually present. The main operator (A.A) should inform 
participants about the possible harms or risks, 
22. Auditing 
The data entered will be conducted by the main supervisor (A.N) and co-supervisor (Y.H) to assure 
quality of the research methods and interventions. The data will be weekly inspected, the 
inconsistencies will be verified, corrected, and registered. 
 Ethics and dissemination 
23. Research ethics approval 
Application forms for carrying out the clinical trial, checklist and informed consent of Research 
Ethics Committee (REC) Faculty of Dentistry, Cairo University will be retrieved and filled, then 
will be delivered for (REC) committee for approval; this is done to prevent any ethical problems 
during the study or any harm for any of the participants. 
24. Protocol amendments:  
If a new protocol will be used, a protocol amendment will be submitted containing a new copy of 
the new protocol and brief explanation about the differences between it and the previous protocols. 
19 If there is a change in the existing protocol that affects the safety of subjects, investigation scope 
or scientific quality of the trial, an amendment containing a brief explanation about the change will 
be submitted. If a new author will be added to accomplish the study, an amendment including the 
investigator's data and qualifications to conduct the investigation will be submitted to prevent ghost 
authorship. 
25. Informed consent: 
The main operator is responsible for admitting and signing the informed consents during the 
enrolment day 
26. Confidentiality 
Name and personal data of the participants will not appear on the protocol form and will be 
maintained secured for 10 years after the trial. This is done for the protection of participants' privacy 
and civil right. 
 
 
 
 

17 
 
27. Declaration of interest 
 
 There is no conflicts of interest pertaining to any of the products or companies discussed in this 
article. 
28. Availability of data 
Access to final data and/or analyzed during the current study will be available from the 
corresponding author on reasonable request. 
29. Ancillary and post-trial care 
The participants will receive dental treatment and checkup during first month, 6 months, 12 months 
and 18 months of the study. 
30. Dissemination policy 
The full protocol will be published online at www.clinicaltrials.gov to avoid repetition and to keep 
the integrity of the research work. The thesis will be discussed in front of judgment committee. The 
study will be published to report the results of this clinical trial. 
 
 Appendices: 
Informed consent will be provided and assigned by the participants. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

18 
 
Faculty of Dentistry Cairo University 
Research Ethics Committee 
Research title: 
Clinical evaluation of three different bioactive restorative materials in cervical 
carious lesions in high caries risk patients: A Randomized Controlled Clinical 
Trial. 
 
Master (   ) PHD/D ( √ ) others (   )  
Name of the researcher: Ahmed Abdul monsif Abdul mohsin Abdul aziz.  
Research objective: clinically evaluate three different bioactive restorative material in cervical 
carious lesion in high caries risk patients, in different follow-up period. 
 
Research procedure in brief (Steps in short) 
 1. Recruitment of the patients and full examination with the diagnosis.  
2. Informed consent taking the eligible participants to participate in the study.  
3. Randomization and allocation into two groups.  
4. Carious removal and cavity preparation then Application of bioactive restorative material. 
5. Follow up and assessment of the restoration after 0 month, 6 months, 12 months and 18 months. 
 
Direct benefit of the research to the human volunteer: 
 
The use of restorations using bioactive restorative material will be benefit for patients as it helps the 
tooth re-mineralization and fuse with the restorative material. This makes the restoration more 
durable and strong to reduce the possibility of new decay. 
 
Scientific value and social benefits:  
 
Evaluating the clinical performance of different bioactive restorative material in cervical carious 
lesion in high caries risk patients will help in reduced risk of post-operative hypersensitivity and 
secondary caries as these materials release ions like calcium, phosphate, and fluoride, which help 
remineralize the surrounding tooth structure and reduce the risk of further decay.  
This is particularly important in cervical lesions, which can be challenging to treat due to their 
location and susceptibility to recurrent caries. 

19 
 
Improved Bond Strength as bioactive materials often have better bonding properties to tooth 
structure, leading to more durable restorations and a reduced risk of leakage. This will be of great 
benefit to society as there minimize rate of failure of restoration due to secondary caries formation 
so no waste of money and time. 
 
Expected risk to the human subjects 
 
The main risk is in the failure or fracture of the restoration.  
 
 
 
Signature: Ahmed Abdul monsif Abdul mohsin Abdul aziz                            Date: 
 
 
 
 Supervisor signature:                                                                                       Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

20 
 
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