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

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

Condition or disease Intervention/treatment Phase
Dental Caries in Children Drug: ACTIVA™ BioACTIVE Drug: Compomer Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: ACTIVA™ BioACTIVE
Restoring cavity using ACTIVA filling material
Drug: ACTIVA™ BioACTIVE
Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth
Other Name: ACTIVA

Active Comparator: Compomer
Restoring cavity using compomer filling material
Drug: Compomer
Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth
Other Name: Dyract




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516838


Contacts
Layout table for location contacts
Contact: Reda Banon, Master +32489060130 reda.banon@gmail.com

Locations
Layout table for location information
Belgium
Ghent University hospital Recruiting
Ghent, Flanders, Belgium, 9000
Contact: Luc Martens, Phd    +3293324008    kindertandheelkunde@ugent.be   
Contact: Reda Banon, MSc    +32489060130    reda.banon@gmail.com   
Principal Investigator: Reda Banon, MSc         
Sponsors and Collaborators
University Ghent
Investigators
Layout table for investigator information
Study Director: Luc Martens, PhD PaeCoMeDis Research group,Ghent University Hospital

Layout table for additonal information
Responsible Party: Reda Banon, Principal Investigator, University Ghent
ClinicalTrials.gov Identifier: NCT03516838     History of Changes
Other Study ID Numbers: EC UZG 2016/1050 - 1051
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available in the literature in the manuscript after publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After publication

Layout table for additional information
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
Keywords provided by Reda Banon, University Ghent:
Dental caries
Class II
Primary molar
Restorative material
Bioactive material
Compomer
Activa bioactive
Ryge criteria
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases