Clinical trial Recruiting at 1 site Interventional Ages 4 to 6

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 typeInterventional
Ages4 Years to 6 Years
SexAll
Enrollment60 (estimated)
SponsorTokat Gaziosmanpasa University
Academic / other
Locations1 site (Tokat Province)
StatusRecruiting
StartedAugust 5, 2024
Main results expectedAugust 5, 2026
Study endsAugust 5, 2026
Registry record updatedJune 4, 2025
Trial IDNCT07003958 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

  • Tokat Gaziosmanpaşa University, Tokat, 60030
    Tokat Province, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.