Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars

NCT07814716 | Recruiting

• 1 other identifier: 8.054.527
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Enamel Hypomineralization

Keywords

orthodontic bands; stainless steel crowns; enamel defects; hspm

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  18 months after treatment

Secondary Outcomes (3)

• Biofilm accumulation

  Immediately after treatment and at 6, 12, and 18 months

• Child-reported treatment acceptability

  Immediately after treatment

• Caregiver-reported treatment acceptability

  Immediately after treatment

Study Arms (2)

Bands

EXPERIMENTAL

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

Crowns

ACTIVE COMPARATOR

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

Interventions

Orthodontic band restorative treatment PROCEDURE

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.

Bands

Hall Technique with preformed stainless steel crown PROCEDURE

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.

Crowns

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59056-000, Brazil

RECRUITING

Related Publications (3)

• Talekar AL, Waggoner WF, Silotry TMH, Musale PK, Chaudhari GS. Prospective, Randomized, Clinical Evaluation of Preformed Zirconia Crowns and Stainless Steel Crowns on Permanent First Molars: 12-Month Results. Pediatr Dent. 2023 May 15;45(3):232-239.

  PMID: 37381120 BACKGROUND

• Bekes K, Steffen R, Kramer N. Hypomineralised second primary molars: the Wurzburg concept. Eur Arch Paediatr Dent. 2024 Aug;25(4):597-602. doi: 10.1007/s40368-024-00913-7. Epub 2024 May 28.

  PMID: 38805129 BACKGROUND

• Bagattoni S, Gozzi I, Lunardon C, Gatto MR, Piana G, Lardani L. Orthodontic Bands for Preventing Post-Eruptive Breakdown in Molars Affected by Molar Incisor Hypomineralisation. Eur J Paediatr Dent. 2025 Sep 1;26(3):212-217. doi: 10.23804/ejpd.2025.2380. Epub 2025 Apr 1.

  PMID: 40243404 BACKGROUND

MeSH Terms

Conditions

Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MsC.

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 11, 2026
• Study Start: November 3, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)