A Clinical Trial on the Failure Rates of Metallic and Ceramic Orthodontic Brackets

NCT05151991 | Completed

• 1 other identifier: 2021-METCERORTO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess if there are significant differences in the failure rate of stainless steel and ceramic brackets. For this study, patients will be enrolled and divided into two groups, according to the type of brackets (stainless steel or ceramic) used for orthodontic treatment. Failure rates will be recorded every month for 12 months and survival analysis will be performed, together with skeletal and space analysis.

Conditions

Dental Malocclusion

Keywords

metallic brackets; ceramic brackets; bond failures; multibrackets therapy; orthodontic treatment; bonding

Outcome Measures

Primary Outcomes (1)

• Failure rates of metallic and ceramic brackets.

  Each month, failed brackets will be recorded. Per each tooth, failure will be recorded once.

  Among the 12 months of the study.

Secondary Outcomes (6)

• Failure rates of metallic and ceramic brackets per sites and sides.

  Among the 12 months of the study.

• ANB angle

  Before the beginning of the orthodontic treatment.

• Wits Index

  Before the beginning of the orthodontic treatment.

• Skeletal Class

  Before the beginning of the orthodontic treatment.

• Dento-alveolar discrepancy

  Before the beginning of the orthodontic treatment.

Study Arms (2)

Groups MET

ACTIVE COMPARATOR

Patients from this group will undergo orthodontic fixed treatment with stainless steel brackets.

Other: Fixed orthodontic treatment with stainless steel brackets

Group CER

ACTIVE COMPARATOR

Patients from this group will undergo orthodontic fixed treatment with ceramic brackets.

Other: Fixed orthodontic treatment with ceramic brackets

Interventions

Fixed orthodontic treatment with stainless steel brackets OTHER

Orthophosphoric acid 37% acid (Gerhò Etchant gel 37%, Gerhò spa, Terlano, Italy) will be applied for 30 s for the etching of the vestibular surfaces of teeth. The, after rinsing and drying, a thin layer of Transbond XT Light Cure Adhesive Primer (3M Unitek, Monrovia, CA, USA) will be applied and then cured for 10 s with a LED unit. At last, Transbond XT Light Cure Adhesive Paste (3M Unitek) will be applied on the base of stainless steel brackets (Queen Series Low Profile Brackets MBT 0.022", Aestetika, Terni, TR, Italy); brackets will be applied on the vestibular surfaces of teeth with a light pressure and the extra paste will be removed. Curing will be performed with the LED unit at 2 mm distant from the enamel-bracket interface for 40 s, 10 s per each surface (mesial, distal, gingival and occlusal). The following sequence of archwires will be adopted for the first six months: 0.012-in Niti, 0.014-in Niti, 0.016-in NiTi, 0.018 SS, 0.020 SS, 0.017X0.025-in NiTi, 0.019X0.025-in SS.

Groups MET

Fixed orthodontic treatment with ceramic brackets OTHER

Orthophosphoric acid 37% acid (Gerhò Etchant gel 37%, Gerhò spa, Terlano, Italy) will be applied for 30 s for the etching of the vestibular surfaces of teeth. The, after rinsing and drying, a thin layer of Transbond XT Light Cure Adhesive Primer (3M Unitek, Monrovia, CA, USA) will be applied and then cured for 10 s with a LED unit. At last, Transbond XT Light Cure Adhesive Paste (3M Unitek) will be applied on the base of ceramic brackets; brackets (Super Clear Series Brackets MBT 0.022", Aestetika, Terni, TR, Italy) will be applied on the vestibular surfaces of teeth with a light pressure and the extra paste is removed. Curing will be performed with the LED unit at 2 mm distant from the enamel-bracket interface for 40 s, 10 s per each surface (mesial, distal, gingival and occlusal). Then, the following sequence of archwires will be adopted for the first six months: 0.012-in Niti, 0.014-in Niti, 0.016-in NiTi, 0.018 SS, 0.020 SS, 0.017X0.025-in NiTi, 0.019X0.025-in SS

Group CER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients willing to begin fixed multibracket therapy with metallic or ceramic brackets;
• full permanent dentition;
• enamel integrity, absence of traumatic or carious lesions, no pretreatment procedure performed with chemical agents;
• no previous orthodontic treatment with fixed vestibular appliances.

You may not qualify if:

• patients suffering from systemic diseases;
• patients taking medications that could alter periodontal conditions (NSAIDS, steroids, etc.);
• patients with low compliance;
• patients unable to give informed consent;
• presence of congenital enamel defects;
• extractions for orthodontic reasons;
• oral/orthognathic surgery.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

Related Publications (1)

• Kirschneck C, Rohn C, Proff P, Reicheneder C. Influence of enamel sealing with a light-cured filled sealant before bracket bonding on the bond failure rate during fixed orthodontic therapy. J Orofac Orthop. 2019 May;80(3):136-143. doi: 10.1007/s00056-019-00174-w. Epub 2019 Apr 10.

  PMID: 30972424 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 9, 2021
• Study Start: December 9, 2021
• Primary Completion: May 4, 2023
• Study Completion: May 8, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)