An interventional study of Orthodontic band restorative treatment and Hall Technique with preformed stainless steel crown in Enamel Hypomineralization, sponsored by Universidade Federal do Rio Grande do Norte. Recruiting at 1 site in Brazil. Open to participants aged 5 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Universidade Federal do Rio Grande do Norte · Not applicable, Interventional, and Treatment
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.
Hypomineralised second primary molars are more susceptible to post-eruptive enamel breakdown, carious lesions, hypersensitivity, and premature tooth loss. Although preformed stainless steel crowns have demonstrated favourable clinical performance in primary molars, orthodontic bands may represent a less invasive restorative approach for maintaining affected teeth until physiological exfoliation. However, their clinical performance in hypomineralised primary teeth has not been investigated.
This parallel-group randomised clinical trial will include 30 children presenting at least one hypomineralised second primary molar with extensive post-eruptive enamel breakdown or a cavitated carious lesion requiring restorative treatment. Participants will be randomly allocated to receive either an orthodontic band cemented with glass ionomer luting cement after restoration of the cavitated lesion or a preformed stainless steel crown placed using the Hall technique. When more than one tooth is eligible, one index tooth will be randomly selected for the primary analysis.
Clinical assessments will be performed immediately after treatment and at 6, 12, and 18 months. Marginal adaptation, retention, and carious lesions adjacent to the restoration margins will be assessed using modified United States Public Health Service criteria. Biofilm accumulation will be assessed using the Silness and Löe Plaque Index. Treatment acceptability will be evaluated immediately after treatment using separate questionnaires for children and caregivers. Physiological exfoliation during follow-up will be recorded separately and will not be considered treatment failure.
20 studies on the registry are indexed under Dental Enamel Hypomineralization; 6 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 15 interventional studies indexed under Dental Enamel Hypomineralization.
Browse Dental Enamel Hypomineralization studies →Universidade Federal do Rio Grande do Norte is the lead sponsor of 86 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Participants allocated to this arm will receive selective removal of softened carious dentine when carious tissue is present, followed by restoration of the cavity with conventional glass ionomer restorative cement (GC Gold Label 9). A prefabricated stainless steel orthodontic band will then be adapted to the index tooth and cemented with glass ionomer luting cement (Meron).
Procedure: Orthodontic band restorative treatment
articipants allocated to this arm will receive a preformed stainless steel crown placed using the Hall technique, without caries removal, local anaesthesia, or tooth preparation. When a large cavity is present, glass ionomer restorative cement (GC Gold Label 9) will be placed at its base without prior caries removal. The crown will be cemented with glass ionomer luting cement (Meron).
Procedure: Hall Technique with preformed stainless steel crown
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.
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.
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.
Time frame: 18 months after treatment
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.
Time frame: 18 months after treatment
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.
Time frame: 18 months after treatment
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.
Time frame: Immediately after treatment and at 6, 12, and 18 months
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.
Time frame: Immediately after treatment
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.
Time frame: Immediately after treatment
Plan to share: No
Started Nov 2025 (actual). Primary completion is estimated for Aug 2028, 33 months after the start.
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Dental Enamel Hypomineralization →
Universidade Federal do Rio Grande do Norte