Using deproteinizing agents before fissure sealants on lower primary molars
Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth: Splint Mouth Clinical Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | Tokat Gaziosmanpasa University Academic / other |
| Locations | 1 site (Tokat Province) |
| Trial ID | NCT07003958 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy, cooperative children aged 4–6 who need fissure sealants on caries-free lower second primary molars.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tokat Province
- Tokat Gaziosmanpaşa University, Tokat, 60030 — Tokat Province, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: alem coşgun
- Email: alemcosgun@hotmail.com
- Phone: +905524133222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.