Comparison of ACTIVA BioACTIVE Versus Compomer in Restoring Dental Decay in Primary Molar Teeth
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|ClinicalTrials.gov Identifier: NCT03516838|
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : May 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries in Children||Drug: ACTIVA™ BioACTIVE Drug: Compomer||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Crossover Assignment|
|Intervention 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 (Participant, Outcomes Assessor)|
|Masking Description:||During treatment, the type of filling material was concealed from the patient, and the patient had no information which material was used in each side of the mouth. The type of material was not mentioned in the patient's file. Instead, it was replaced by a combination which the outcomes assessors were not familiar with. The operator was also blinded for the type of restoration during tooth preparation and was informed only at the time of restoration placement. The purpose of this discretion was to ensure double blinding both at the patient, as well as the outcomes assessor level.|
|Official Title:||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|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2021|
Experimental: ACTIVA™ BioACTIVE
Restoring cavity using ACTIVA filling material
Drug: ACTIVA™ BioACTIVE
Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth
Other Name: ACTIVA
Active Comparator: Compomer
Restoring cavity using compomer filling material
Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth
Other Name: Dyract
- 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
- 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
- Radiographic evaluation [ Time Frame: 12 months follow-up ]Check the filling radiographically based on Rx photo by a blinded and calibrated assessor
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516838
|Contact: Reda Banon, Masteremail@example.com|
|Ghent University hospital||Recruiting|
|Ghent, Flanders, Belgium, 9000|
|Contact: Luc Martens, Phd +3293324008 firstname.lastname@example.org|
|Contact: Reda Banon, MSc +32489060130 email@example.com|
|Principal Investigator: Reda Banon, MSc|
|Study Director:||Luc Martens, PhD||PaeCoMeDis Research group,Ghent University Hospital|