A Phase 4 interventional study of ACTIVA™ BioACTIVE and Compomer in Dental Caries in Children, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 3 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by University Ghent · Phase 4, Interventional, and Treatment
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
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.
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Exclusion Criteria:
Restoring cavity using ACTIVA filling material
Drug: ACTIVA™ BioACTIVE
Restoring cavity using compomer filling material
Drug: Compomer
Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth
Also known as: ACTIVA
Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth
Also known as: Dyract
Clinical evaluation
Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor
Time frame: 6 months follow-up
Clinical evaluation
Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor
Time frame: 12 months follow-up
Radiographic evaluation
Check the filling radiographically based on Rx photo by a blinded and calibrated assessor
Time frame: 12 months follow-up
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.
Time frame: Immediately after each intervention
Plan to share: Yes — The data will be available in the literature in the manuscript after publication
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University Ghent