The Effect of Different Deproteinising Agents on the Clinical Success of Fissure Sealants in Permanent Teeth

Not Applicable

Recruiting

• Conditions: Fissure Sealant

• Registration Number: NCT06988098
• Lead Sponsor: Tokat Gaziosmanpasa University

Brief Summary

Investigation of the effect of deproteinization agents on the clinical success of non-invasive fissure sealant application, which is a non-invasive method used to prevent caries formation or to stop the progression of initial caries lesions limited to enamel on tooth surfaces thought to be at high risk of caries.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients between the ages of 6-9 who do not have any systemic problems
• Have a score of 3 and 4 on the Frankl Behavior Scale
• Do not have a habit of clenching and/or grinding their teeth
• Have newly erupted permanent lower first molars without caries
• Have an indication for fissure sealant application

Exclusion Criteria

• Teeth with fissure sealants
• Teeth with developmental defects such as hypoplasia
• Teeth with approximal or incipient caries lesions on one or both mandibular first permanent molars
• Children who are not systemically healthy
• Uncooperative children with scores of 1 and 2 on the Frankl Behavior Scale
• Children and parents who refuse to attend follow-up appointments
• Children with parafunctional habits such as teeth grinding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Modified Simonsen Criteria	Following the sealant application, controls will be made at 6, 12, 24 and 36 months.	Modified Simonsen Criteria; Score 0 Fissure sealant is completely in the mouth and there is no new caries.; Score 1 Partial loss of fissure sealant, no new caries.; Score 2 Partial loss of fissure sealant and new caries.; Score 3 Complete loss of fissure sealant, no new caries.; Score 4 Complete loss of fissure sealant and new caries.

Secondary Outcome Measures

Name	Time	Method
Edge Integrity Evaluation Criteria	Following the sealant application, controls will be made at 6, 12, 24 and 36 months.	Edge Integrity Evaluation Criteria; 0 The fissure sealant and tooth surface are intact and cannot be distinguished with a probe.; 1. The edges of the fissure sealants can be distinguished with a probe.; 2. There is a gap along the edge of the fissure sealant and deep cracks reaching the central fossa.

Trial Locations

Locations (1)

Tokat Gaziosmanpaşa University; 🇹🇷 Tokat, Turkey