Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing | NCT07725133

NCT07725133

Overview

NCT ID: NCT07725133
Lead Sponsor: Marmara UniversityOTHER
Official Title: Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing: A Split-Mouth Randomized Clinical Trial
Brief Summary: This randomized split-mouth clinical trial will compare two methods of occlusal surface cleaning before pit and fissure sealant placement in children aged 6-10 years.

In each participant, eligible permanent first molars will receive either erythritol-based Guided Biofilm Therapy or conventional rotary-brush polishing before phosphoric acid etching and placement of the same resin-based sealant. Each child will receive both interventions on opposite sides of the mouth.

The sealants will be followed for up to 36 months to determine whether the surface-cleaning method influences sealant retention and clinical performance. Procedure-related discomfort will also be compared between the two methods.
Conditions: Pit and Fissure Sealant Retention

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Children aged 6-10 years presenting to the Department of Pediatric Dentistry, Marmara University Faculty of Dentistry, for routine dental treatment.

Systemically healthy individuals classified as ASA I.

Children who are cooperative and able to maintain communication throughout the clinical procedure.

Presence of at least two comparable permanent first molars with unrestored occlusal surfaces that are either caries-free or have initial lesions limited to the pit and fissure level.

Exclusion Criteria:

Individuals with systemic diseases (e.g., diabetes, epilepsy, cardiovascular diseases), classified as ASA II or higher.

Individuals who have used antibiotics, anti-inflammatory drugs, or immunosuppressive medications within the past 3 months.

Children who are unable to communicate due to emotional, psychological, or developmental disorders.

Individuals with previously placed pit and fissure sealants on their permanent first molars.

Presence of deep carious lesions, restorations, or structural defects such as molar-incisor hypomineralization (MIH) in the teeth planned for inclusion in the study.