NCT07262502

Evaluation of the Clinical Success of Hydrophilic Fissure Sealants

EVALUATION OF THE CLINICAL SUCCESS OF A HYDROPHILIC FISSURE SEALANT APPLIED TO LOWER PERMANENT MOLARS UNDER DRY AND WET CONDITIONS

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Afyonkarahisar Health Sciences University · Academic / Other
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Accepted

Summary

The study group will consist of children aged 7-11 years who are systemically healthy and who apply to the Pediatric Dentistry Clinic of the Faculty of Dentistry, Afyonkarahisar Health Sciences University for routine dental treatment. In the study, fissure sealants will be applied to the first molars with opposing deep pits and fissures in the same jaw. The study will involve the application of fissure sealants to the first molars with opposing deep pits and fissures in the same jaw. It was decided to include a total of 500 teeth from 250 patients in the study, with 250 teeth in each group. The occlusal surface of each tooth will be dried and etched with 37% phosphoric acid (Eco-Etch; Ivoclar Vivadent, Inc. Schaan, Liechtenstein) and thoroughly rinsed for 30 seconds. If saliva contamination occurs, the surface will be etched again. The treated tooth will be air-dried for 3 seconds and the tooth in the opposing jaw for 15 seconds. Subsequently, the relevant fissure sealant (Pulpdent, Embrace Wetbond Pit and Fissure Sealant) will be applied to the occlusal surface of each tooth and cured for 20 seconds using a light-curing unit at an intensity of 500 mW/cm². After restoration, articulation paper will be used to check for any high spots in the occlusion; if found, excess material will be removed using a finishing bur. Clinical evaluations of marginal integrity, marginal color change, and retention after the liner is placed will be performed at 3, 6, 9, and 12 months using the World Health Organization probe according to the Ryge and Synder criteria.

Conditions

• Pit and Fissure Caries (Disorder)
• Pit and Fissure Sealants

Interventions

Type	Name	Description
OTHER	pit and fissure sealant	For each tooth to be treated with pit and fissure sealant, phosphoric acid will be used for pre-treatment. One group will be dried with an air-water spray for 3 seconds, while the drying time for the other group of teeth in the opposing jaw will be 15 seconds.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

1 site across 1 country: Turkey (Türkiye)