Orthodontic band restorative treatmentHall Technique with preformed stainless steel crown
Orthodontic band restorative treatment: 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: 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.
Study 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
Sex
ALL
Min age
5 Years
Max age
10 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Marginal adaptation — 18 months after treatment 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 — 18 months after treatment 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 — 18 months after treatment 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.
Trial sites (1)
Facility
City
Region
Status
Federal University of Rio Grande do Norte
Natal
Rio Grande do Norte
Recruiting
More Universidade Federal do Rio Grande do Norte trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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