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The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars

Study acronym: ResinFS
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Jun 5, 2025 → Sep 5, 2027
See other at-risk trials from University of Dublin, Trinity College

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 5, 2025 to Sep 5, 2027 Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Jun 5, 2027 to Sep 30, 2027
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 13 words
    • Site details revised
    • Publications: details revised at 13 of 14 entries
  2. Primary endpoint revised
    • Secondary endpoints revised (2)
    • Study description shortened, about 554 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Resin-based fissure sealants (FS) are recommended to prevent pit-and-fissure caries development or prevent the progression of enamel caries lesion to frank cavitation into dentine. There is still limited clinical evidence on the use of adhesive system beneath fissure sealants in permanent molars and its effect on FS retention and caries progression. Aim: The aim of this randomised clinical trial is to evaluate the clinical efficacy of fissure sealants placed with and without prior use of an adhesive system in terms of retention and caries prevention in permanent molars over the period of 2 years. Study design: Children (6-12 years of age) with high caries risk that require sealants in their first permanent molars (ICDAS 0-3) will be selected at the Dublin Dental University Hospital (DDUH). Molars will be stratified according to presence of caries lesions (ICDAS 0 or ICDAS1-3) and randomly allocated according to the study groups (Test group: 17% phosphoric acid + adhesive system + FS; Control group: 17% phosphoric acid + FS). The randomisation unit will be the tooth and more than one tooth can be included per child. All children will be evaluated after 12 and 24 months by calibrated independent examiners. The primary outcome of the present trial is sealant retention over time. Clinical variables such as age, gender, tooth position (upper/lower), caries experience (DMFT/dmft), stage of eruption (erupted/partially erupted) and children's behavior (Frankl scale) will be collected.
Trial Details
NCT Number NCT06608563
Lead Sponsor University of Dublin, Trinity College
Conditions
(from sponsor)		 Dental Caries, Fissure Sealant
Related terms Dental Caries
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov