Enamel Hypomineralization
Conditions
Keywords
orthodontic bands, stainless steel crowns, enamel defects, hspm
Brief 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.
Detailed description
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.
Interventions
PROCEDUREOrthodontic 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.
PROCEDUREHall 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.
Sponsors
Universidade Federal do Rio Grande do Norte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biofilm accumulation | Immediately after treatment and at 6, 12, and 18 months | 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 | Immediately after treatment | 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 | Immediately after treatment | 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. |
Countries
Brazil
Outcome results
None listed