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.
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.
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.
Parallel
Orthodontic band restorative treatment
Procedure/SurgerySelective 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/SurgeryPlacement 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.
Marginal adaptation
Marginal adaptation will be assessed using modified United States Public Health Service criteria: Alpha, continuous margin without a detectable gap; Bravo, minor discontinuity not requiring clinical intervention; and Charlie, marginal defect requiring repair or replacement. Alpha and Bravo will be considered clinically satisfactory, whereas Charlie will be considered a failure.
Retention
Retention will be classified as Alpha when the orthodontic band or stainless steel crown remains firmly cemented and functional, or Charlie when it is lost or dislodged and requires recementation or replacement. Alpha will be considered successful retention and Charlie a failure.
Presence of carious lesions
Carious lesions adjacent to the restoration margins will be assessed clinically and classified as Alpha when absent or Charlie when present. Alpha will be considered clinically satisfactory and Charlie a failure.
Biofilm accumulation
Biofilm accumulation will be assessed using the Silness and Löe Plaque Index, ranging from 0 to 3: 0, absence of biofilm; 1, thin biofilm film along the free gingival margin; 2, moderate accumulation within the gingival sulcus; and 3, abundant accumulation within the gingival sulcus. Lower scores indicate less biofilm accumulation.
Child-reported treatment acceptability
Acceptability will be assessed using a five-item questionnaire. Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20. The negatively worded item will be reverse-scored. Higher total scores indicate greater treatment acceptability.
Caregiver-reported treatment acceptability
Acceptability will be assessed using a five-item questionnaire. Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20. Higher total scores indicate greater treatment acceptability.
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