Orthodontic bands vs stainless steel crowns for hypomineralised second primary molars
Official title: Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars: a Randomised Clinical Trial
Run by Universidade Federal do Rio Grande do Norte · NCT07814716 · Data updated 2026-11-12
This study tests whether orthodontic bands or preformed stainless steel crowns work better to restore badly affected baby molars in children aged 5–10.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 10 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Universidade Federal do Rio Grande do Norte Academic / other |
| Locations | 1 site (Natal, Rio Grande do Norte) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | August 2028 |
| Study ends | July 2029 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07814716 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children 5–10 years old with at least one hypomineralised second primary molar needing restoration.
✕Probably not a fit
Children without eligible teeth or with contraindications may not benefit from the tested approaches.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this parallel-group randomized trial, 30 children with hypomineralised second primary molars are assigned to receive either an orthodontic band or a preformed stainless steel crown (Hall technique) for restoration. Outcomes are measured immediately after treatment and at 6, 12, and 18 months, focusing on marginal adaptation, retention, caries around the restoration, biofilm accumulation, and acceptability to children and caregivers. The study uses modified USPHS criteria for restoration assessment and the Silness and Löe Plaque Index for biofilm evaluation. One index tooth per participant is analyzed for primary outcomes, with random selection if multiple eligible teeth exist. The goal is to determine which technique provides better durability and acceptance in managing enamel-hypomineralised primary molars.
Why it matters
Potential benefit: If successful, the findings could guide clinicians in choosing a restoration method that preserves primary teeth longer and improves patient comfort.
How similar studies have gone: Previous work supports stainless steel crowns in primary molars, but direct comparison with orthodontic bands in hypomineralised teeth is not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, Brazil Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.