Using deproteinizing agents before fissure sealants on lower primary molars
Official title: Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth: Splint Mouth Clinical Study
Run by Tokat Gaziosmanpasa University · NCT07003958 · Data updated 2026-11-12
This trial tests whether applying deproteinizing agents like sodium hypochlorite or hypochlorous acid before placing fissure sealants improves sealant success in healthy children aged 4–6.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 6 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Tokat Gaziosmanpasa University Academic / other |
| Locations | 1 site (Tokat Province) |
| Status | Recruiting |
| Started | August 5, 2024 |
| Main results expected | August 5, 2026 |
| Study ends | August 5, 2026 |
| Registry record updated | June 4, 2025 |
| Trial ID | NCT07003958 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy, cooperative children aged 4–6 who need fissure sealants on caries-free lower second primary molars.
✕Probably not a fit
Children with existing sealants, developmental enamel defects, approximal or incipient caries on the targeted molars, or significant clenching/grinding habits are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial applies deproteinization agents (sodium hypochlorite or hypochlorous acid) to the fissures of lower second primary molars prior to fissure sealant placement and monitors clinical outcomes. Eligible participants are healthy children aged 4–6 with cooperative behavior (Frankl 3–4) and caries-free mandibular second primary molars. Teeth with existing sealants, developmental defects, or approximal/incipient caries are excluded. Clinical sealant retention and caries-related outcomes will be recorded at scheduled follow-up visits after application.
Why it matters
Potential benefit: If successful, the approach could reduce sealant failures and lower early childhood cavity rates in treated primary molars.
How similar studies have gone: Prior dental research has shown mixed evidence that deproteinization with agents like sodium hypochlorite can improve bonding and sealant retention, so the approach is promising but not yet standard.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between the ages of 4-6 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 lower second primary 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 second primary molars
Where it's running
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Tokat Gaziosmanpaşa University, Tokat, 60030
Tokat Province, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: alem coşgun
- Email: alemcosgun@hotmail.com
- Phone: +905524133222
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.