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NCT07814716
Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars: a Randomised Clinical Trial
Conditions: Enamel Hypomineralization
Sex: All
Ages: 5 Years – 10 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Universidade Federal do Rio Grande do Norte
Location: Federal University of Rio Grande do Norte Natal Rio Grande do Norte
Summary
This randomised clinical trial will compare the clinical performance and acceptability of orthodontic bands and preformed stainless steel crowns for the restorative management of hypomineralised second primary molars. Thirty children aged 5-10 years will be randomly allocated in a 1:1 ratio to receive either an orthodontic band or a stainless steel crown. One index tooth per participant will be evaluated immediately after treatment and at 6, 12, and 18 months. The primary outcomes will be marginal adaptation, retention, and the presence of carious lesions. Secondary outcomes will include biofilm accumulation and treatment acceptability among children and their caregivers.
Eligibility Criteria
Inclusion Criteria:
* Children aged 5-10 years.
* Presence of at least one second primary molar affected by hypomineralised second primary molars requiring restorative treatment.
* Hypomineralisation associated with post-eruptive enamel breakdown involving more than one tooth surface or a cavitated carious lesion involving more than one surface and classified as code 5 or 6 according to the International Caries Detection and Assessment System.
Exclusion Criteria:
* Extensive carious lesion with subgingival margins.
* Clinical or radiographic signs of pulpal inflammation or necrosis.
* Advanced physiological root resorption indicating imminent exfoliation of the eligible tooth.
* Previous restorative treatment of the eligible tooth.
* Presence of bruxism.
Source: ClinicalTrials.gov (NCT07814716). StuddyBuddy aggregates publicly available trial information.