Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars

January 12, 2019 updated by: Alaa Fathi Abdelsalam, Cairo University

Clinical Evaluation of Bioactive Resin Based Pits & Fissures Sealants Versus Conventional Resin Based Pits & Fissures Sealants in Caries Susceptible Fissures in Permanent Molars: A Randomized Controlled Trial

This study will be conducted to evaluate the performance; in terms of retention and caries inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus conventional resin based pits and fissure sealant in caries susceptible fissures in posterior molars in patients at risk of caries. Evaluation will be done by visual tactile examination & VistaCAM.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the investigator's study the comparator material will be BioCoat® by Premier® ; new bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™ Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium and phosphate ions is assumed.

With limited evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it was found beneficial to evaluate the newly introduced material using a randomized controlled trial to test the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as conventional resin based pits and fissure sealant in susceptible fissures.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria of participants:

  • Patients with bilateral caries susceptible fissures in molars showing no signs of caries.
  • 19 - 40 years.
  • Males or Females.
  • Co-operative patients approving to participate in the trial.

Exclusion criteria of participants:

  • Patients younger than 19 years old or older than 40 years old.
  • Pregnancy.
  • Disabilities.
  • Systemic disease or severe medical complications.
  • Allergic history concerning methacrylate.
  • Rampant caries.
  • Heavy smoking.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional group
Conventional resin based Pits & fissures sealant 3M™ Clinpro™ Sealant is administrated
Combination product: 3M™ Clinpro™ Sealant.
conventional pits and fissure sealant
Experimental: bioactive group
Bioactive Pits & fissures sealant BioCoat® by Premier®.
Combination product: BioCoat® by Premier®.
Bioactive pits and fissure sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of sealant
Time Frame: one year
rate of sealant loss
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries incidence
Time Frame: one year
rate of caries initiation
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 12, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14011989

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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