Clinical trial NCT03788616
Conditions: Dental Caries
Keywords: Bioactive Restorative Material , ART
Sponsor: Marina F Fahmy, MD
Start date: 2018-11-17; Completion date: 2019-11-17
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will be two parallel group, triple blinded randomized controlled clinical trial that based on CONSORT (consolidated standards of reporting trials) guideline .The selected participants according to inclusion and exclusion criteria will be randomly allocated in two groups using (Research Randomizer Program) .

Detailed description:
Blinding All participants don't know the type of received restorative material (ACTIVA Kids or High -viscosity GI restorative material) and the outcome will be evaluated by a examiner other than operator who doesn't know the type of received restorative material also.

Study setting The study will be performed at pediatric Department and Dental Public Health Department of Faculty of Dentistry, Ain Shams University, and at the institute of Graduate Studies and Research, Ain Shams University.

Sample size: 60 participants Recruitment/Setting The all participants of this study have been selected after complete clinical examination has been done with full medical and dental history , history of medications and history of hospitalization. In patients who receive dental treatment as an usual care in clinics of Pediatric Dentistry and Dental Public Health Department at faculty of dentistry, Ain-Shams University.

Informed consent designed to include all data about dental procedures in this study and clear more details about time consuming in the procedure and follow up visits, used materials and adverse event of this procedure . All participants have the wright to withdraw from this study at any time .The consent will be assigned from each patient by the patient's parents or guardians after explanation of the study.

The full mouth rehabilitation will be performed by postgraduate student registered at the master Degree at the Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Ain- Shams University All subjects receive instructions on oral health, particularly in relation to oral hygiene and sugar consumption

Arms: arm 1: Group I : will consist of 30 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach arm 2: Group II : will consist of 30 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.
Interventions: intervention 1: Fuji IX EXTRA intervention 2: ACTIVA KIDS bioactive restorative material
Intervention descriptions: intervention 1: High-viscosity glass ionomer (Fuji IX EXTRA) intervention 2: Modified composite (ACTIVA KIDS)

Protocol documents:
Prot_SAP_000.pdf: 
PED18-5M 
 
“Evaluation of Fluoride Release and Compressive Strength of a Bioactive 
Restorative Material and its Clinical Performance in Atraumatic Restorative 
Treatment in primary molars : an in vitro study & a randomized controlled  
trial” 
Submitted by 
Marina Fakhry Fahmy  
BDS 2013 
Resident at Pediatric Dentistry and Dental Public Health Department   
Faculty of Dentistry - Ain Shams University 
Thesis protocol  
Submitted In Partial Fulfillment of the Requirements 
 of Master Degree in Pediatric Dentistry 
Supervisors 
Dr.Amr Mahmoud Abd EL Aziz 
Professor & Head of Pediatric Dentistry and Dental Public Health Department 
Faculty of Dentistry-Ain Shams University 
Dr. Reham Khaled Abou El Fadl 
Lecturer of Pediatric Dentistry and Dental Public Health Department 
Faculty of Dentistry-Ain Shams University 
 
 
Faculty of Dentistry  
 Ain Shams University 
"February 14, 2018"  
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List of CONTENTS 
 
1- Introduction/Background……………………………....page 3-4 
2- Aim of the Study………………………………………...page 5 
3- Materials and Methods………………………………….page 6-12 
4- Study Population ………………………………………. page 8  
5- Study Procedure………………………………………....page13-14 
6-Data Management………………………………………..page 15 
7-Adverse Event Reporting…………………………….….page 16 
8- Statistical Analysis………………………………………page 17 
9- References………………………………………..……...page 18-20 
 
 
 
 
 
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INTRODUCTION 
Although the prevalence of dental caries has been declined in industrialized countries, this 
disease continues to be widespread in the world especially in developing countries .Once it has 
become installed, it is of importance to use conservative  procedures that simultaneously prevent 
caries progression and minimize healthy tooth structure wear . The most serious problem 
encountered during caries removal is anxiety, fear and pain. Pressure and heat during mechanical 
preparation and the annoying noise from the handpiece are to blame. Furthermore, Conventional 
caries removal involved the use of drilling often causes over preparation of sound healthy dentin 
because the drill remove infected and affected dentin, leading sometimes to pulp inflammation 
and even exposure.   
This was perceived as unpleasant and painful by many patients, so local anesthesia had to be 
administered to control pain. System for caries removal and cavity preparation have been under 
strong pressure for development towards minimal invasive procedures and increased patient 
comfort. 
During the last few decades, many alternative methods for cavity preparation and caries removal 
have been introduced, including atraumatic restorative treatment. 
Atraumatic Restorative Treatment (ART) is a minimally intervention approach that concerned 
with preventive measures, sealing and filling cavities .The restorative technique needs the 
removal of the infected, softened and demineralized dentin by use of hand instruments, followed 
by the application of a chemical –adhesive material (1,2) for management of caries. This 
approach, that is an effective and economical method to prevent and control caries lesion 
progression, causes less dental anxiety and discomfort to the patients than conventional rotary 
instruments used in conventional restorative treatment.(3) 
Initially, ART was recommended by the World Health Organization for escorting restorative 
care to people without access to dental services (2). ART was originally developed for 
economically underdeveloped populations with limited resources (4). It also has applications in 
industrial countries, however, especially for:  very young children who are being introduced to 
oral care (5), patients who experience extreme fear or anxiety about dental Procedures(6,7), 
mentally and/or physically handicapped patients (7,8) ,home-bound elderly and nursing home 
resident patients (9,10) ,and patients from high-risk caries clinics who can benefit from ART as 
an intermediate treatment to stabilize conditions (5,11) .   
 
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ART has been proven to be a high quality and reliable approach in the management of dental 
caries, and became suitable for all patients, regardless of the economic and social situation 
(12,13) 
ART has many advantages especially in pediatric dentistry as less anxiety, less pain and rarely 
requires local anesthesia (14).  
A meta-analysis of ART showed that high-viscosity GICs presented  higher clinical survival 
rates than conventional or medium-viscosity glass ionomers (15) so High-Viscosity Glass 
ionomer cements (GICs) is the most used material for the ART approach due to their biological, 
physical, and chemical properties (16). Notably, hand mixing of GICs might allow for an 
increased incidence of operator errors during material preparation, as the ratio of powder to 
liquid may vary according to manufacturer's recommendations(17). The quantity of powder 
dispensed varies according to powder packing density in the volumetric scoop. The volume of 
liquid dispensed from the manufacturer-supplied dropper bottle varies depending on the angle at 
which the bottle is held, the pressure applied to squeeze a drop, and the inclusion of air 
bubbles(17). With the purpose of decreasing these variables, encapsulated dental cements have 
been introduced in the market(18). These premade mixtures utilize mechanical mixing methods 
and allow standardization of the powder/liquid ratio in a sealed capsule, which is expected to 
reduce variation in clinical outcomes(18,19). 
Resin modified GI are formulated by incorporating a small quantity of resin monomers and 
initiators into GI material in order to improve some of mechanical properties the clinical 
performance of RMGIs ,however, remain inferior to the resin composite material (20) 
A novel restorative material has been developed as enhanced RMGIs (ACTIVA BIOACTIVE 
restorative).the resin monomer added to ACTIVA BIOACTIVE restorative are claimed to impart 
resilience to the material to improve its mechanical properties . this material are an esthetic 
fluorinated dental restorative material, with promising claims to be more bioactive and release 
more fluoride than glass ionomer cement (21) they are moisture friendly , transport water , and 
stimulate apatite formation at the material-tooth interface.in addition , these resins react to PH 
changes in the mouth by releasing and up-taking calcium ,phosphate and fluoride ions .  
ACTIVA-BIOACTIVE restorative material claims to possesses characteristics of both composite 
and resin modified glass ionomer (RMGI) as strength, esthetics and physical properites of 
composites , Seals teeth against bacterial  Leakage (22,23) and release and recharge more of 
calcium, phosphate and fluoride than glass ionomer (21) However, there is few studies evalute 
the clinical performance and mechanical properties of  ACTIVA BIOACTIVE restorative 
material versus other restorative material . 
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AIM OF THE STUDY 
 
The aim of this study is : 
 
1- Evaluate the fluoride release capacity and compressive strength of a new bioactive restorative 
material . 
 
2- Evaluate and compare the clinical performance and survival rates of bioactive restorative 
material with high viscosity glass ionomer in class I restoration performed using Atraumatic 
Restorative Treatment approach in primary molars. 
 
 
 
 
 
 
 
 
 
 
 
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Materials and Methods 
 In Vitro Study 
Materials 
Material name: 
ACTIVA BIOACTIVE restorative 
material 
Fuji IX  
Manufacture: 
 Pulpdent , Watertown, MA USA 
GC America 
Material type: 
Enhanced resin modified glass 
ionomer 
High-viscosity glass ionomer 
 
Grouping of the specimens: 
                                                                                     
 
ACTIVA BIOACTIVE 
restorative material 
 
   
                                                                                              
 
 
 
High- Viscosity Glass 
Ionom 
 
             
Page 6 of 20 
1 Day 
3M
1M 
7 Day 
Compressive  Strength 
Fluoride Release 
1Day 
3M 
1M 
7Day 
Fluoride Release 
Compressive strength 


PED18-5M 
 
Sample size:   
The sample size estimation was done using Steven K. Thompson equation and assuming power 
90% and effect size 0.05  
 
 
With:- 
n (sample size) 
N (population size) =90,000,000 
p (probability value or p-value) =0.11 
z (standard score or z-score)=1.96 
d (difference between paired data or Effect Size) =0.5 
So the resultant n = 28.07 
 
Sample size analysis for compressive strength and fluoride release testing was calculated to be 
28 specimens that will be distrubted as 7 in each experimental group (four groups ) according to  
data collected from previous studies . 
 
  Methods: 
I-Compressive strength 
*Preparation of the specimens: Specimens will be prepared in split Teflon mold 
according to ISO Guidelines specification No. 9917-1:2007(E) (24). 
 
The material will be proportioned and mixed according to the manufacturer's instructions 
and then placed in special mold up to a slight excess. The mold will be closed and placed under 
pressure using a screw clamp. The whole assembly will be transferred to an incubator and 
maintained at a temperature of 37 ºC. One hour after  mixing, the specimens will be removed 
from the mold, finished using wet silicon carbide paper and stored in water in an incubator at a 
temperature of 37 ºC  until the time of testing.  
                                                             
                      
                                                                    page 7 of 20 
 


PED18-5M 
 
*Testing procedures: 
 
Compressive strength and for each material will be measured after 24 hours. Each 
specimen will be placed with the flat ends of the specimen between the platens of the universal 
testing machine and compressive load will be applied along the long axis of the specimen. 
 
The load at fracture for each specimen, will be recorded and compressive strength will be 
calculated as follows (25) . 
            CS = 4P/π d2      
 
Where: p is the maximum load applied in Newtons. 
            d is the measured diameter of  specimen, in millimeters. 
 
II-Fluoride release : 
 
* Preparation of the specimens: 
 
Specimens will be prepared in split Teflon mold and then removed after one hour from 
mixing. The specimens will be finished and then coated with glass ionomer varnish and will be 
stored in water for 24 hours in an incubator at a temperature of 37 ºC, then the specimens will be 
removed from the water and dried. 
 Each specimen will be immersed in deionized water in plastic bottles and will be stored in an 
incubator at 37°C till the time of testing. At the time of testing, each plastic bottle will be 
thoroughly shaken and then the specimen will be removed, dried and returned into a new bottle 
containing deionized water. 
*Testing procedures: 
 
The fluoride ion release will be measured after storage in deionized water for 1 day, 7 
days, 1 month and 3 months using fluoride ion-selective electrode (ISE) attached to an ion meter. 
 In Vivo study 
Study Population      
Total of 60participants will be included in this study. 30 of them will be treated with (ACTIVA           
BIOACTIVE) restorative material in ART, 30 will be treated with (High-Viscosity glass 
ionomer ) restorative material in ART. 
          Inclusion Criteria: 
1-Children aged from 4 to 8 years old, in good general health  
2-Children classified as class 3or 4 based on Frankle et al. classification. (26) 
3-The children have at least one primary molar with class I carious lesion. 
3- Asymptomatic teeth (without spontaneous pain)  
                                                                         page 8 of 20 
 


PED18-5M 
 
 
Exclusion Criteria: 
1. Medically compromised patient 
2. Presence of pulp exposure, pain, mobility 
3. Presence of swelling, abscess or fistula near the tooth 
4. Not accessible carious lesion to hand instruments 
 
Study design : 
The study will be two parallel group, double blinded randomized controlled clinical trial that 
based on CONSORT (consolidated standars of reporting trials) guideline (27).The selected 
participant according to inclusion and exclusion criteria will be randomly allocated in two groups 
using (Research Randomizer Program) . 
Blinding 
All paticipant don't know the type of received restorative material (ACTIVA BIOATIVE or 
Heigh -viscosity GI restorative material) and the outcome will be evaluted by a examiner other 
than operator who doesn't know the type of received restorative material also. 
Study setting  
The study will be performed at pediatric Department and Dental Puplic Health Department of 
Faculty of Dentistry, Ain Shams University, and at the institute of Graduate Studies and 
Research, Ain Shams University. 
Sample size 
The sample size estimation was done using Steven K. Thompson equation and assuming power 
90% and effect size 0.05  
 
                                                                        Page 9 of 20 


PED18-5M 
 
With:- 
 n (sample size) 
N  (population size)=90,000,000 
p (probability value or p-value) =0.07 
z (standard score or z-score)=1.96 
d (difference between paired data or Effect Size)=0.05 
So the resultant n = 60 
Recruitment/Setting  
The all participants of this study have been selected after compelet clinical examination has been 
done with full medical and dental history , history of medications and history of hospitalization. 
In patients  who receive dental treatment as an usual care in clinics of Pediatric Dentistry and 
Dental Public Health Department at faculty of dentistry, Ain-Shams University.           
Informed consent designed to include all data about dental procedures in this study and clear 
more details about time consuming in the procedure and follow up visits, used materials and 
adverse event of this procedure . All participants have the wright to withdraw from this study at 
any time .The consent will be assigned from each patient by the patient’s parents or guardians 
after explanation of the study. 
The full mouth rehabilitation will be performed by postgraduate student registered at the master 
Degree at the Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, 
Ain- Shams University      
All subjects receive instructions on oral health, particularly in relation to oral hygiene and sugar 
consumption. 
Material  
Material name: 
ACTIVA 
BIOACTIVE 
restorative material 
Fuji IX 
Manufacture: 
PULPDENT 
GC America 
Material type: 
Enhanced resin modified glass 
ionomer 
High-viscosity      
 glass ionomer 
 
                                                                        
                                                                 Page 10 of 20 


PED18-5M 
 
Sample Grouping 
The 60 participant will be randomly divided into two group according to used material as follow: 
Group I (control): will consist of 30 teeth that will be restored with conventional Atraumatic 
restorative treatment (ART) using by high-viscosity glass ionomer (Fuji IX) 
Group II: will consist of 30 teeth that will be restored with Atraumatic Restorative Treatment 
(ART) using ACTIVA BIO ACTIVE restorative material 
Steps of Procedure in group  (control): 
Atraumatic Restorative Treatment (ART) performed according to Frencken et al. guidelines (28)   
 ►► Maintain relative isolation of the operatory field with cotton rolls. 
►► Remove caries: using only hand excavators compatible with the size of the carious cavity. 
Both infected and affected dentin should be removed from the dentin–enamel junction.the 
affected dentin will be maintained in the remaining walls. Thin, unsupported 
enamel was carefully removed using a hatchet placed on the enamel with slight pressure. 
►► Clean the cavity: cavity walls should be cleaned with cotton balls moistened with water  
►► Condition the dentin: apply a drop of 11.5% polyacrylic acid on a cotton ball for 15 s. 
Then, wash the cavity with three cotton balls moistened with water and dry using three more 
cotton balls. 
►►encapsulated GIC(Fuji IX), the plunger was placed on a hard surface and a mechanical 
mixer was used to mix the capsules for 10 seconds. The capsule was then placed into the 
applicator to insert the GIC into the cavity. 
 ►►After inserting the GIC, a gloved finger coated with petroleum jelly was used to apply 
pressure to the GIC for 1 minute.  
►► Occlusion was checked and excess material was removed with a carver. Restorations were 
coated with a layer of petroleum jelly to prevent sorption during occlusal checking. 
►►petroleum jelly was removed from the surface using at least two cotton wool pellets. GC 
Coat  was applied to the surfaces of final restorations and light-cured for 20 seconds 
►► Instruct the patient not to eat solid food for 1 hour. 
                                                                                 Page 11 of 20 
 


PED18-5M 
 
Steps of Procedure in group :   
►► Maintain relative isolation of the operatory field with cotton rolls. 
►► Remove caries: using only hand excavators compatible with the size of the carious cavity. 
Both infected and affected dentin should be removed from the dentin–enamel junction.the 
affected dentin will be maintained in the remaining walls. Thin, unsupported 
enamel was carefully removed using a hatchet placed on the enamel with slight pressure. 
►► Clean the cavity: cavity walls should be cleaned with cotton balls moistened with water and 
dry using three more cotton balls. 
►► Insert a ACTIVA BIOACTIVE restorative material to the cavity without application of  
acid etching or bond 
►► Occlusion was checked and excess material was removed with a carver. 
►► Instruct the patient not to eat solid food for 1 hour. 
 
 
 
 
 
 
 
 
 
 
Page 12 of 20 
 


PED18-5M 
 
Study procedure 
In VIVO Study 
Atraumatic Restorative Treatment will be formed by two different restorative materials 
(ACTIVA BIOACTIVE and High- viscosity Glass ionomer) and long term survival of 
restorative material will be  evaluated  at 3,6 and 9 months . 
Outcomes 
The outcome of this study is the longevity of ACTIVA BIOACTIVE restorative material versus 
high –viscosity glass ionomer in (ART) in Class I carious cavity of primary teeth 
 Longevity of the restoration 
Treatment longevity will be evaluated clinically after 3, 6 and 9 months according to the 
Frencken and Holmgren criteria (29) in the  class I restorations using sharp sickle shaped 
explorers, WHO CPI periodontal probes, which has a ball tip with 0.5 mm diameter,plane 
mirrors, and light source of dental unit. 
The codes and criteria used to evaluate the ART restorations are found in the Table 
Score  
Criteria(17) 
0 
Present, good 
1 
Present, slight marginal defect for whatever reason, at any one 
place which is less than 0.5 mm in depth. 
No repair is needed. 
2 
Present, marginal defect for whatever reason, at any one place 
which is deeper than 0.5 mm but less than 1.0 mm. 
Repair is needed. 
3 
Present, gross defect of more than 1.0 mm in depth. 
Repair is needed. 
4 
Not present, restoration has (almost) completely disappeared. 
Treatment is needed. 
5 
Not present, other restorative treatment has been performed. 


PED18-5M 
 
 
 
 
 
 
 
 
 
 
 
Note : Restorations considered to have survived are scored by codes: 0,1,7; those considered to 
have failed by codes: 2,3,4,8; while those that are considered to be unrelated to success and 
failure are codes:5,6 
 
 
 
 
 
 
 
 
 
Page 14 of 20 
6 
Not present, tooth has been extracted. 
7 
Present wear and tear gradually over larger parts of the 
restoration but is less than 0.5 mm at the deepest point. 
No repair is needed. 
8 
Present, wear and tear gradually over larger parts of the 
restoration which is deeper than 0.5 mm 
Repair is needed. 
9 
Unable to diagnose 


PED18-5M 
 
Data Management: 
            
            All data will be entered electronically. 
            Participant’s data  will be stored in numerical order in secure place and limited access files. Soft 
copies of the files will be protected by password access. 
            The hard copy will be kept confidential and private with the investigator throughout the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Adverse Event Reporting 
Adverse events in vivo part of study : 
1-partial or compelet failure of restoration that will need to be repaired 
2-recurrent caries around restorations  
3-Inflammatory reactions of pulps of restored teeh that will need pulp therapy 
4-Infection of pulp of restored teeth that may develop an abscess or facial celluitis which will 
need pulp therapy or extraction with or without space maintainer.  
5-time consuming during dental perocedure and follow up visits  
Adverse events in vitro part of study  
There is no adverse events in this part. 
 
 
 
 
 
 
Page 16 of 20 
 


PED18-5M 
 
Statistical analysis 
Data will be collected, tabulated, and statistically analyzed using suitable statistical test to 
achieve the aim of this study . 
 
 
 
 
 
 
 
 
 
 
 
 
Page 17 of 20 
 


PED18-5M 
 
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treatment(ART): rationale, technique, and development.J Public Health Dent. 
1996;56(3 Spec No):135-40. 
https://doi.org/10.1111/j.1752-7325.1996.tb02423.x 
 
2- Frencken JE, Holmgrem CJ. Atraumatic Restorative treatment 
for dental caries. Nijmegen: STI Book; 1999. 
 
3- Arrow P, Klobas E. Minimum intervention dentistry approach to  
managing early childhood caries: a randomized control trial. Community  
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5. American Academy of Pediatric Dentistry. Policy onalternative restorative 
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6. Schriks MC, van Amerongen WE. Atraumatic perspectiveof ART: 
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21- Slowikowski L, et al. Fluoride ion release and recharge over time in three 
restoratives. J Dent Res 93 (Spec Iss A): 268, 2014 (www.iadr.org). 
 
22.Zmener O, Pameijer CH, Hernandez S. Resistance against bacterial leakage of 
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