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

NCT03516838 | Completed Phase 4

• 1 other identifier: EC UZG 2016/1050 - 1051
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Caries in Children

Keywords

Dental caries; Class II; Primary molar; Restorative material; Bioactive material; Compomer; Activa bioactive; Ryge criteria

Outcome Measures

Primary Outcomes (3)

• Clinical evaluation

  Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor

  6 months follow-up

• Clinical evaluation

  Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor

  12 months follow-up

• Radiographic evaluation

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

  12 months follow-up

Secondary Outcomes (1)

• Time needed to place the filling material

  Immediately after each intervention

Study Arms (2)

ACTIVA™ BioACTIVE

EXPERIMENTAL

Restoring cavity using ACTIVA filling material

Drug: ACTIVA™ BioACTIVE

Compomer

ACTIVE COMPARATOR

Restoring cavity using compomer filling material

Drug: Compomer

Interventions

ACTIVA™ BioACTIVE DRUG

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

Also known as: ACTIVA

ACTIVA™ BioACTIVE

Compomer DRUG

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

Also known as: Dyract

Compomer

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University hospital

Ghent, Flanders, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 38600533 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Compomers; Dyract

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Composite Resins; Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Luc Martens, PhD

  PaeCoMeDis Research group,Ghent University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: May 4, 2018
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication

Locations

BE (1)