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

Dental Caries in Children Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516838
• Other study ID #: EC UZG 2016/1050 - 1051
• Status: Completed
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: November 2023
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Drug:
• ACTIVA™ BioACTIVE
Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth
• Compomer
Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth

Locations

Country	Name	City	State
Belgium	Ghent University hospital	Ghent	Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation	Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor	6 months follow-up
Primary	Clinical evaluation	Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor	12 months follow-up
Primary	Radiographic evaluation	Check the filling radiographically based on Rx photo by a blinded and calibrated assessor	12 months follow-up
Secondary	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.	Immediately after each intervention