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OpenTrials
Completed

NCT Number: NCT03516838

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

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

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ghent University hospital

Ghent, Flanders, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ACTIVA™ BioACTIVE

Drug

Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth

Other names: ACTIVA

Compomer

Drug

Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth

Other names: Dyract

Primary outcomes

  1. 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

  2. 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

  3. Radiographic evaluation

    Time frame: 12 months follow-up

    Check the filling radiographically based on Rx photo by a blinded and calibrated assessor

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 4, 2018
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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