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RECRUITING Not applicable ClinicalTrials.gov

Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars

Sponsor: Universidade Federal do Rio Grande do Norte • ClinicalTrials.gov ID: NCT07814716

Registry updated: 2026-09-15
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Description

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.

Interventions

  • Orthodontic band restorative treatment (Procedure)
    Selective removal of softened carious dentine, when present, followed by restoration with conventional glass ionomer cement and placement of a prefabricated stainless steel orthodontic band cemented with glass ionomer luting cement.
  • Hall Technique with preformed stainless steel crown (Procedure)
    Placement of a preformed stainless steel crown using the Hall technique, without caries removal, local anaesthesia, or tooth preparation. The crown will be cemented with glass ionomer luting cement.

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.

Conditions

Enamel Hypomineralization

Locations

  • Federal University of Rio Grande do Norte — Natal, Rio Grande do Norte, Brazil
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record