Retention and Caries Prevention of Giomer Sealant With or Without Diode Laser Pre-treatment: A Randomized Controlled Trial

NCT07612540 | Not Yet Recruiting

• 1 other identifier: Fissure sealant
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 3

Brief Summary

This randomized controlled trial evaluates the effect of diode laser pre-treatment on the retention and caries prevention of giomer-based fissure sealants in young adults aged 17-22 years. The study compares sealant application with and without diode laser conditioning on molars with ICDAS 0-2 fissures over a 12-month follow-up period. Primary outcome is sealant retention using Simonsen's criteria, while secondary outcome is caries prevention using modified USPHS criteria. The study hypothesizes that diode laser pre-treatment may improve sealant retention and enhance caries prevention by modifying enamel surface characteristics and improving sealant penetration.

Conditions

Dental Caries

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.

  1 year

Secondary Outcomes (1)

• Secondary Caries

  1 year

Study Arms (3)

Giomer Based Sealant Without Pre Treatmen

ACTIVE COMPARATOR

Giomer Based Sealant Without Pre Treatment With laser giomer based fissure sealnt will be applied without surface treatment

Other: phosphoric acid pretreatment

Giomer Based Sealant With etchant Pre Treatmen

ACTIVE COMPARATOR

Giomer Based Sealant Without Pre Treatment With laser giomer based fissure sealnt will be applied with phosphoric acid surface treatment

Other: phosphoric acid pretreatment

Giomer Based Sealant With laser Pre Treatmen

ACTIVE COMPARATOR

Giomer Based Sealant with laser Pre Treatment giomer based fissure sealnt will be applied with laser surface treatment

Other: phosphoric acid pretreatment

Interventions

phosphoric acid pretreatment OTHER

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

Also known as: laser pretreatment

Giomer Based Sealant With etchant Pre Treatmen; Giomer Based Sealant With laser Pre Treatmen; Giomer Based Sealant Without Pre Treatmen

Eligibility Criteria

• Age: 17 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (3)

Faculty of Dentistry Cairo University

Cairo, Egypt

Location

Faculty of Dentistry

Cairo, Egypt

Location

Yomna

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

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

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

EG (3)