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

RecruitingNAAges 5 Years - 10 YearsAllUniversidade Federal do Rio Grande do Norte
NCT07814716 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Orthodontic band restorative treatment
  • Hall Technique with preformed stainless steel crown
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Where

1 site
Federal University of Rio Grande do Norte
Natal, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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