Condition: Dental Caries · Fissure Sealant · Sponsor: University of Dublin, Trinity College
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) wil…
This description comes directly from the study's public registry record.
Rona Leith, BDentSc DChDent · +353 01 6127303 · rona.leith@dental.tcd.ie
Grace Gill, Division 1 Secretary · +353 016127303 · grace.gill@dental.tcd.ie
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| Dublin Dental University Hospital - Trintiy College Dublin | Dublin, Dublin, Ireland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06608563