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NOT YET RECRUITING
NCT07725133
NA

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

Sponsor: Marmara University

View on ClinicalTrials.gov

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.

Official title: Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing: A Split-Mouth Randomized Clinical Trial

Key Details

Gender

All

Age Range

6 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-07-20

Completion Date

2029-10-20

Last Updated

2026-07-24

Healthy Volunteers

Yes

Interventions

DEVICE

Device: Guided Biofilm Therapy with erythritol

Permanent first molars assigned to Group 1 will receive occlusal surface cleaning using the AIRFLOW® Prophylaxis Master device (EMS, Switzerland) with AIRFLOW® Plus Powder containing approximately 99% erythritol and a particle size of approximately 14 μm. The powder will be applied for 5 seconds from a distance of approximately 2 mm under suction. The tooth surface will then be etched with 37% phosphoric acid for 15 seconds, followed by the application of Clinpro™ Sealant (3M ESPE, USA), which will be light-cured for 15 seconds.

DEVICE

Device: Conventional Polishing

Permanent first molars assigned to Group 2 will receive occlusal surface cleaning using conventional polishing with a rotary prophylaxis brush. The tooth surface will then be etched with 37% phosphoric acid for 15 seconds, followed by the application of Clinpro™ Sealant (3M ESPE, USA), which will be light-cured for 15 seconds.

Locations (1)

Marmara University

Istanbul, Maltepe, Turkey (Türkiye)