NCT06003452

Brief Summary

Prevention of oral diseases is preferable to treatment and is the key method of achieving cost effectiveness for oral health improvement programs. Various preventive strategies for dental caries have been tried and are still being developed. The occlusal pits and fissures of posterior teeth are highly susceptible to caries because of the anatomy of pit and fissure surfaces, which favours stagnation of bacteria and substrates. Fissure sealing has been shown to be an evidence-based caries preventive method for protecting the occlusal surfaces against caries. Non- sealed teeth need to be restored approximately 50% more frequently compared to their sealed counterpart. Sealants are effective caries preventive agents as long as they remain bonded to teeth. It has been proposed that sealants should be placed on both sound teeth and incipient non-cavitated carious lesions on permanent teeth of high caries risk patients in order to prevent the onset of caries and its progression. According to the American Dental Association Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended for sealant application.A variety of dental materials have been used as sealants using different application techniques. Their effectiveness depends on the formation of a complete seal and is increased by correct technique and moisture control, appropriate follow-up and resealing as necessary. Resin-based conventional sealants are preferred choice, however use of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is more technique sensitive.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

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

First Submitted

Initial submission to the registry

August 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

August 15, 2023

Last Update Submit

January 30, 2026

Conditions

Keywords

Fissure sealantBio-active glasscaries prevention

Outcome Measures

Primary Outcomes (1)

  • Loss of sealant's retention

    Simonsen's criteria Full retention (FR) The material was fully present on the occlusal surfaces Partially lost (PL) The material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed \- Totally lost (TL) No trace of the material was detected on the surface.

    6 months

Secondary Outcomes (1)

  • Secondary Caries

    6 months

Study Arms (2)

Giomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion

ACTIVE COMPARATOR

giomer based fissure sealnt will be applied without surface treatment

Procedure: surface treatment with Bioactive Glass Air Abrasion

Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air Abrasion

EXPERIMENTAL

giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion

Procedure: surface treatment with Bioactive Glass Air Abrasion

Interventions

giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion

Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air AbrasionGiomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion

Eligibility Criteria

Age17 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Young adult Patients Aged 17-22.
  • Good oral hygiene (plaque index score 0 or 1).
  • Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
  • Patients approving to participate in the study.

You may not qualify if:

  • Patients with known allergic or adverse reaction to the tested materials.
  • Systematic disease that may affect participation.
  • Xerostomic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at faculty of dentistry Cairo university

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 22, 2023

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

April 1, 2025

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations