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Evaluation of the Clinical Success of Hydrophilic Fissure Sealants

NCT07262502 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-12-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Afyonkarahisar Health Sciences University

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-03-01
Completion
2026-04-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07262502 on ClinicalTrials.gov