Clincosm LogoSign in Get a demo

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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03779893
Collaborator
(none)
38
Enrollment
2
Arms
14
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: BioCoat® by Premier®.
  • Combination Product: 3M™ Clinpro™ Sealant.
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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
Anticipated Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Retention of sealant [one year]

    rate of sealant loss

Secondary Outcome Measures

  1. Caries incidence [one year]

    rate of caries initiation

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alaa Fathi Abdelsalam, principle investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT03779893
Other Study ID Numbers:
  • 14011989
First Posted:
Dec 19, 2018
Last Update Posted:
Jan 15, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dental Caries

Study Results

No Results Posted as of Jan 15, 2019