NCT05891288

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

May 22, 2023

Last Update Submit

March 20, 2025

Conditions

Caries; Initial

Outcome Measures

Primary Outcomes (1)

  • Retention of sealant

    rate of sealant loss

    2 years

Secondary Outcomes (1)

  • Caries incidence

    2 years

Study Arms (2)

bioactive group

EXPERIMENTAL

Bioactive Pits \& fissures sealant BioCoat® by Premier®.

Other: BioCoat® by Premier®

Comparator group

ACTIVE COMPARATOR

Fluoride releasing resin based Pits \& fissures sealant 3M™ Clinpro™ Sealant

Other: 3M™ Clinpro™ Sealant.

Interventions

BioCoat® by Premier®OTHER

Bioactive pits and fissure sealant

bioactive group
3M™ Clinpro™ Sealant.OTHER

Fluoride releasing pits and fissure sealant

Comparator group

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with bilateral initial carious fissures in molars showing no signs of caries.
  • Co-operative patients approving to participate in the trial.

You may not qualify if:

  • Sound fissures.
  • Pregnancy.
  • Disabilities.
  • Systemic disease or severe medical complications.
  • Rampant caries.
  • Heavy smoking.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, El Manial, 11553, Egypt

Location

Related Publications (1)

  • Abdelsalam AF, Shaalan O. 24-month efficacy of bioactive versus fluoride sealant for non-cavitated occlusal caries in adults: a randomized clinical trial. Sci Rep. 2025 Dec 11;15(1):43738. doi: 10.1038/s41598-025-29730-8.

    PMID: 41381619DERIVED

Study Officials

  • Omar Shaalan

    Lecturer, Department of Conservative Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Conservative Dentistry

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 6, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)