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Recruiting NCT06988098

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

No phase Interventional Fissure Sealant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: application of deproteinization agents.
Who it may be relevant to
Registry conditions: Fissure Sealant. Basic parameters: 6 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Permanent Teeth: Splint Mouth Clinical Study

Overview

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.

Interventions

  • Other application of deproteinization agents
    Since there is no in vivo study in the literature evaluating the clinical success of the use of hypochlorous acid for deproteinization in fissure sealants, our planned study is the first in this regard.

Primary outcome measures

  • Modified Simonsen Criteria [Time frame: Following the sealant application, controls will be made at 6, 12, 24 and 36 months.]
Secondary outcome measures (1)
  • Edge Integrity Evaluation Criteria [Time frame: Following the sealant application, controls will be made at 6, 12, 24 and 36 months.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Tokat Gaziosmanpaşa University — Tokat Province

Publications

  • Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res. 2000 Nov;79(11):1850-6. doi: 10.1177/00220345000790110601. PMID 11145354
  • Simonsen RJ. Retention and effectiveness of dental sealant after 15 years. J Am Dent Assoc. 1991 Oct;122(10):34-42. doi: 10.14219/jada.archive.1991.0289. PMID 1835987

Identifiers

NCT: NCT06988098 · 23-19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗