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

University Ghent

Status and phase

Completed

Phase 4

Conditions

Dental Caries in Children

Treatments

Drug: Compomer

Drug: ACTIVA™ BioACTIVE

Study type

Interventional

Funder types

Other

Identifiers

NCT03516838

EC UZG 2016/1050 - 1051

Details and patient eligibility

About

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

Full 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.

Enrollment

35 patients

Sex

All

Ages

3 to 10 years old

Volunteers

Accepts Healthy Volunteers

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)