Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket

NCT ID: NCT02959671

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-01-31

Brief Summary

A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of brackets on the remaining mandibular teeth. Tooth movement will be initiated using 0.014" or 0.016" Nickel-Titanium archwires.

A second cohort of 15 patients will receive EXD-952 Ceramic Self-ligating bracket on all mandibular incisors in a later phase of their ongoing orthodontic treatment. The mandibular incisor brackets will be removed and EXD-952 Ceramic Self-ligating brackets placed instead. Other mandibular brackets will remain in place. Tooth movement will be performed using 0.019x0.025" Stainless Steel archwires.

In both cohorts bracket door stability, the ability of the door to hold the archwire in the bracket slot, the bracket's ability to rotate teeth, clinicians' satisfaction with the bracket, and patient comfort in comparison with other brackets will be assessed.

The evaluation for each patient will last for at least until one archwire change (cohort 1) or one appointment interval (6-8 weeks, cohort 2).

After the evaluation period, EXD-952 Ceramic Self-ligating brackets will remain in place until the orthodontic treatment is completed.

Conditions

Malocclusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lower Anterior EXD-952 Self-ligating Brackets

Group Type: EXPERIMENTAL

Lower Anterior EXD-952 Self-ligating Brackets

Intervention Type: DEVICE

Placement of EXD-952 Self-ligating Brackets on mandibular incisors

Interventions

Lower Anterior EXD-952 Self-ligating Brackets

Placement of EXD-952 Self-ligating Brackets on mandibular incisors

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Permanent mandibular dentition including incisors, canines, premolars, and first molars (includes subjects treated with the extraction of premolars)
• Mandibular incisors with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide

Exclusion Criteria

• Mental/emotional/developmental disability
• Inability to give informed consent
• Cleft lip and/or palate, craniofacial anomaly, or syndrome
• Obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions
• Prosthodontic or restored substrate extending on the labial surface of mandibular incisors
• Deep bite
• Known allergies to any study materials

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3M Oral Care

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1611M00321

Identifier Type: -

Identifier Source: org_study_id