Clinical Efficiency of Bioactive Pit and Fissure Sealant

July 2, 2024 updated by: Samaa Salah Eldin Abd Elfattah, Cairo University

Clinical Evaluation of Bioactive Versus Filled Resin Based Pit & Fissure Sealants in First Permanent Molars: A Randomized Controlled Trial

This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

New bioactive resin pits and fissures sealant BioCoat® by Premier® presenting SmartCap™ Technology involving semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, supposing greater fluoride uptake in the presence of calcium and phosphate ions.

With no enough evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it isd beneficial to evaluate the newly introduced material using a randomized clinical trial to test the null hypothesis that bioactive resin pit and fissure sealant will have the same clinical performance as flouride releasing filled resin based pit and fissure sealant in susceptible fissures.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Inclusion Criteria of participants:

    • Patients with caries susceptible fiss- ures in fully erupted first permanent molars showing nosigns of caries.
    • Co-operative patients approving to part- icipate in the trial.
    • Good oral hygiene.

  • Inclusion Criteria of teeth:

    • Caries susceptible occlusal pits and fissures.
    • Intact contact with opposing teeth.
    • Teeth with no previous restorations in other surfaces.

Exclusion Criteria:

  • Exclusion criteria of participants:

    • patients with Disabilities, systemic disease or severe medical complications.
    • patients have allergic history concerning methacrylate.
    • patients with rampant caries, xerostomia, evidence of severe bruxism, clenching, or tempromandibular joint disorders
    • participants who show lack of compliance.

  • Exclusion criteria of teeth:

    • Carious pits and fissures.
    • Developmental tooth defect.
    • Partially erupted teeth
    • Periapical pathology or signs of pulpal pathology.
    • Tooth hypersensitivity.
    • Heavy occlusion and occlusal contacts.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group (A)
Fluoride releasing filled resin based pit and fissure sealant using UltraSeal XT™ plus by Ultradent
Other: UltraSeal XT™ plus by Ultradent
UltraSeal XT plus is a 58%-filled resin fluoride-releasing sealant. It is strong and has high wear resistant
Experimental: Interventional group (B)
Bioactive pit and fissure sealant using BioCoat® by Premier®
Other: BioCoat® by Premier®
BioCoat is a 56% filled resin formula that provides added strength and excellent long-term resistance to wear ؤomparable to flowable composites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of sealant
Time Frame: 1 year
rate of sealant loss
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries incidence
Time Frame: 1 year
Rate of caries progression
1 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 (Estimated)

August 1, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BPFS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

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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