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.
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.
Individuals with systemic diseases (e.g., diabetes, epilepsy, cardiovascular diseases), classified as ASA II or higher.
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.
Parallel
Device: Guided Biofilm Therapy with erythritol
DevicePermanent 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: Conventional Polishing
DevicePermanent 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.
Pit and Fissure Sealant Retention Assessed Using the Modified Simonsen Criteria
Pit and fissure sealant retention will be clinically assessed at the tooth level using the Modified Simonsen Criteria. Score 0 indicates no sealant loss and no caries; Score 1 indicates partial sealant loss without caries; Score 2 indicates partial sealant loss with caries; Score 3 indicates complete sealant loss without caries; and Score 4 indicates complete sealant loss with caries. A score of 1, 2, 3, or 4 at any follow-up visit will be considered retention failure and achievement of the primary endpoint.
Clinical Performance of Pit and Fissure Sealants Assessed Using Modified USPHS Criteria
The clinical performance of the pit and fissure sealants will be evaluated at the tooth level using the Modified United States Public Health Service criteria. The evaluated domains will include marginal adaptation, secondary caries, anatomical form, surface roughness, color match, marginal discoloration, and postoperative sensitivity. Each domain will be rated as Alpha, Bravo, or Charlie, as applicable, with Alpha indicating optimal clinical performance and Charlie indicating clinically unacceptable performance or the need for intervention.
Fissure Sealant Retention According to the Tonn and Ryge Criteria
Pit and fissure sealant retention will be clinically assessed using the Tonn and Ryge criteria. Score 0 indicates complete retention, with the sealant material completely present on the occlusal surface; Score 1 indicates partial loss or the presence of cracks; and Score 2 indicates complete loss of the sealant. Higher scores indicate poorer sealant retention.
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