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RECRUITING
NCT07814716
NA

Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars: a Randomised Clinical Trial

Sponsor: Universidade Federal do Rio Grande do Norte

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

5 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-11-03

Completion Date

2029-07

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

PROCEDURE

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.

PROCEDURE

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.

Locations (1)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil