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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pit and Fissure Caries (Disorder); Pit and Fissure Sealants
• Intervention / Treatment: Other: pit and fissure sealant

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Afyonkarahisar
    • Afyonkarahisar, Afyonkarahisar, Turkey (Türkiye), 03030
      • Afyonkarahisar Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Patients aged 7-11 who applied for dental examination at the Department of Pediatric Dentistry, Faculty of Dentistry, Afyon Health Sciences University.

  2. Patients must be systemically healthy and have no mental or physical disabilities.

  3. Permanent first molars must be fully erupted in the mouth, and at least 3 first molars must be indicated for non-invasive fissure sealant application (having narrow, deep fissures prone to decay).

  4. Permanent first molars to receive fissure sealants must not have hypomineralized areas such as fluorosis or first molar incisal hypomineralization.

  5. Permanent first molars must not have occlusal or approximal caries.

Exclusion Criteria:

• 1. Patients must not be between the ages of 7 and 11. 2. Patients must not be systemically healthy and must have no mental or physical disabilities.

  3. Patients must have poor oral hygiene. 4. There must be caries in the permanent first molars where fissure sealants will be applied.

  5. Presence of hypomineralized areas such as fluorosis or first molar hypomineralization on the permanent first molars where fissure sealants will be applied.

  6. Patients not cooperating with the procedures to be performed. 7. Patients or their parents not wanting to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pit and fissure sealant treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edge discoloration	A: No color change between the restoration and the tooth structure B: Localized, mostly removable superficial color change C: Pulpal discoloration	3-6-9-12 months

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Preventive Dentistry; pit and fissure sealants
• Additional Relevant MeSH Terms: Van der Woude syndrome; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Dental Materials; Pit and Fissure Sealants
• Other Study ID Numbers: 24.DUS.010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No