Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03516838
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Reda Banon, University Ghent

Tracking Information
First Submitted Date  ICMJE April 22, 2018
First Posted Date  ICMJE May 4, 2018
Last Update Posted Date May 4, 2018
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • 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
  • 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
  • Radiographic evaluation [ Time Frame: 12 months follow-up ]
    Check the filling radiographically based on Rx photo by a blinded and calibrated assessor
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of ACTIVA BioACTIVE Versus Compomer in Restoring Dental Decay in Primary Molar Teeth
Official Title  ICMJE 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
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
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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

Masking: Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Dental Caries in Children
Intervention  ICMJE
  • Drug: ACTIVA™ BioACTIVE
    Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth
    Other Name: ACTIVA
  • Drug: Compomer
    Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth
    Other Name: Dyract
Study Arms  ICMJE
  • Experimental: ACTIVA™ BioACTIVE
    Restoring cavity using ACTIVA filling material
    Intervention: Drug: ACTIVA™ BioACTIVE
  • Active Comparator: Compomer
    Restoring cavity using compomer filling material
    Intervention: Drug: Compomer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2018)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Reda Banon, Master +32489060130 reda.banon@gmail.com
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03516838
Other Study ID Numbers  ICMJE EC UZG 2016/1050 - 1051
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The data will be available in the literature in the manuscript after publication
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: After publication
Responsible Party Reda Banon, University Ghent
Study Sponsor  ICMJE University Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Luc Martens, PhD PaeCoMeDis Research group,Ghent University Hospital
PRS Account University Ghent
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP