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

NCT ID: NCT03516838

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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ACTIVA™ BioACTIVE

Restoring cavity using ACTIVA filling material

Group Type EXPERIMENTAL

ACTIVA™ BioACTIVE

Intervention Type DRUG

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

Compomer

Restoring cavity using compomer filling material

Group Type ACTIVE_COMPARATOR

Compomer

Intervention Type DRUG

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

Interventions

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ACTIVA™ BioACTIVE

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

Intervention Type DRUG

Compomer

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

Intervention Type DRUG

Other Intervention Names

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ACTIVA Dyract

Eligibility Criteria

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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)
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc Martens, PhD

Role: STUDY_DIRECTOR

PaeCoMeDis Research group,Ghent University Hospital

Locations

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Ghent University hospital

Ghent, Flanders, Belgium

Site Status

Countries

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Belgium

References

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Banon R, Vandenbulcke J, Van Acker J, Martens L, De Coster P, Rajasekharan S. Two-year clinical and radiographic evaluation of ACTIVA BioACTIVE versus Compomer (Dyract(R) eXtra) in the restoration of class-2 cavities of primary molars: a non-inferior split-mouth randomised clinical trial. BMC Oral Health. 2024 Apr 10;24(1):437. doi: 10.1186/s12903-024-04132-w.

Reference Type DERIVED
PMID: 38600533 (View on PubMed)

Other Identifiers

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EC UZG 2016/1050 - 1051

Identifier Type: -

Identifier Source: org_study_id