Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement

NCT ID: NCT05281588

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-03-31

Brief Summary

This clinical trial evaluated the efficacy of micro osteoperforations in accelerating the retraction of maxillary incisors.

Detailed Description

This single-centered randomized clinical trial evaluated the effects of micro-osteoperforations in the retraction of maxillary incisors in patients who required the extraction of the first premolars to correct malocclusion. The canine retraction was performed in a previous step. The possible effects of micro-osteoperforantions in the following parameters were evaluated in the upper arch: anteroposterior incisors and first molars displacement, space closure, inclination and length of central incisors.

Conditions

Orthodontic Tooth Movement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Micro-osteoperforations

Micro-osteoperforations- assisted upper incisors retraction

Group Type: EXPERIMENTAL

Micro-osteoperforations

Intervention Type: PROCEDURE

All micro-osteoperforations were performed only one time in the experimental group on the same day of the installation of the upper incisors' retraction mechanics. Perforations were performed with an individualized surgical guide and a 1.6 mm diameter stainless steel surgical drill perpendicular to the alveolar bone, 3 mm deep on the buccal surface, and 5 mm, on the palate. The depth of the perforations was controlled and standardized by a cursor developed and patented by the research group. Two micro-osteoperforations were aligned vertically distally from each upper incisor. Due to the proximity of the roots in the cervical third, only the most apical perforation was performed between the two central incisors. The first perforation was performed 6 mm away from the gingival margin, and the second, 5 mm from the first, in the vertical direction.

Control

Upper incisors retraction not associated with any clinical intervention to accelerate tooth movement

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Micro-osteoperforations

All micro-osteoperforations were performed only one time in the experimental group on the same day of the installation of the upper incisors' retraction mechanics. Perforations were performed with an individualized surgical guide and a 1.6 mm diameter stainless steel surgical drill perpendicular to the alveolar bone, 3 mm deep on the buccal surface, and 5 mm, on the palate. The depth of the perforations was controlled and standardized by a cursor developed and patented by the research group. Two micro-osteoperforations were aligned vertically distally from each upper incisor. Due to the proximity of the roots in the cervical third, only the most apical perforation was performed between the two central incisors. The first perforation was performed 6 mm away from the gingival margin, and the second, 5 mm from the first, in the vertical direction.

Intervention Type: PROCEDURE

Other Intervention Names

MOP

Eligibility Criteria

Inclusion Criteria

• both male and female subjects
• 16 or more years old
• orthodontic need of upper incisors extractions
• presence of all upper permanent teeth with exception of the third molars.

Exclusion Criteria

• diseases and medications that were likely to affect bone biology
• pregnancy
• poor oral hygiene
• previous orthodontic treatment
• evidence of bone loss
• active periodontal disease
• smoking
• syndromes or cleft patients
• severe crowding or Class II malocclusion (Pg-Nper > 18 mm, ANB > 7º, SN-GoGn > 38º e overjet > 10 mm).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: collaborator

Pontifícia Universidade Católica de Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rodrigo V Soares, PhD

Role: STUDY_DIRECTOR

Pontifícia Universidade Católica de Minas Gerais

Locations

Pontifícia Universidade Católica de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

Micro-osteoperforations

Identifier Type: -

Identifier Source: org_study_id