Clinical trial NCT03516838: Comparison of ACTIVA BioACTIVE Versus Compomer in Restoring Dental Decay in Primary Molar Teeth
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries in Children
Keywords: Dental caries
Class II
Primary molar
Restorative material
Bioactive material
Compomer
Activa bioactive
Ryge criteria
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Clinical evaluation
timeFrame: 6 months follow-up
measure: Clinical evaluation
timeFrame: 12 months follow-up
measure: Radiographic evaluation
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Time needed to place the filling material
timeFrame: Immediately after each intervention
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University hospital
state: Flanders
Study officials:
affiliation: PaeCoMeDis Research group,Ghent University Hospital
name: Luc Martens, PhD
role: STUDY_DIRECTOR
References: