Comparison of ACTIVA BioACTIVE Versus Compomer in Restoring Dental Decay in Primary Molar Teeth
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Flanders
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Ghent, Flanders, Belgium, 9000
- Ghent University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACTIVA™ BioACTIVE
Restoring cavity using ACTIVA filling material
|
Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth
Other Names:
|
|
Active Comparator: Compomer
Restoring cavity using compomer filling material
|
Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical evaluation
Time Frame: 6 months follow-up
|
Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor
|
6 months follow-up
|
|
Clinical evaluation
Time Frame: 12 months follow-up
|
Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor
|
12 months follow-up
|
|
Radiographic evaluation
Time Frame: 12 months follow-up
|
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 Frame: Immediately after each intervention
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Luc Martens, PhD, PaeCoMeDis Research group,Ghent University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC UZG 2016/1050 - 1051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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