Comparison of ACTIVA BioACTIVE Versus Compomer in Restoring Dental Decay in Primary Molar Teeth

Study Overview
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Brief Summary
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A clinical trial to evaluate a filling material (ACTIVA) and compare it to a traditional filling material (compomer) to restore decayed deciduous teeth in children

Detailed Description
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A tooth decay in deciduous teeth has to be restored with proper filling material. ACTIVA™ BioACTIVE is a new filling material which has the ability to release and recharge fluoride in the oral cavity which is important for preventing further tooth decay. In this study we will compare this new filling material with Compomer (the traditional control filling material) by restoring decayed deciduous molars with one of the mentioned filling materials. Both filling materials have no reported adverse effect and used regularly in the dental practice. The treatment procedure is performed in healthy children from both genders with decayed deciduous molars aged between 5 to 10 years by one operator in the dental chair under local anesthesia in the department of pediatric dentistry and special care, Ghent University hospital, Ghent, Belgium. At least 35 teeth is needed to demonstrate an effect. Each material is placed randomly based on randomization done by the computer. Each participant will receive both types of treatments, one type on each side of the mouth. The participants will come back each six months to check the success of each treatment group by two trained dentists other than the operator. and to check whether the control group performs similar, better or worse than the control group. The duration of treatment procedure of both treatment groups is recorded and compared to check if one filling material takes less time than the other to placed in the oral cavity.

Official Title
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Clinical and Radiographic Evaluation of a New Bioactive Ionic Resin Material (ACTIVA™ BioACTIVE) Versus Compomer for Class II Restorations in Primary Molars: A Split Mouth Randomized Clinical Trial

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Drug: ACTIVA™ BioACTIVE
* Drug: Compomer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children with American Society of Anesthesiologists (ASA) I score from both gender aged between three and ten years Vital decayed deciduous molar with proximal enamel/dentine caries At least one decayed tooth on each side of the mouth (split mouth) Pt is treatable in the dental chair Parents agreed to participate in the study and signed the informed consent Exclusion Criteria: Patients with medical conditions or systemic disease Anxious or uncooperative patients who are not treatable in the dental chair Any symptoms like: pain, swelling, abscess or fistula. Extensive caries, dental developmental disturbance, pathological mobility, pulp exposure or indication for pulp therapy Patients with one decayed tooth in the whole mouth (not split mouth)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Experimental prospective double blinded split-mouth randomized controlled trial . Each patient receive both types of treatment in the oral cavity, one type of the treatment on each side. The patients act as their control
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTIVA™ BioACTIVE<br>Restoring cavity using ACTIVA filling material | Drug: ACTIVA™ BioACTIVE<br>* Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth<br>* Other names: ACTIVA;|
| Active Comparator: Compomer<br>Restoring cavity using compomer filling material | Drug: Compomer<br>* Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth<br>* Other names: Dyract;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation | Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor | 6 months follow-up | 
| Clinical evaluation | Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor | 12 months follow-up | 
| Radiographic evaluation | Check the filling radiographically based on Rx photo by a blinded and calibrated assessor | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to place the filling material | Time since start placing the filling material until finishing the restoration is recorded and compared between the two groups to investigate whether both materials take the same time to be placed in the oral cavity. | Immediately after each intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compomer, Ryge criteria, Dental caries, Class II, Primary molar, Restorative material, Bioactive material, Activa bioactive