Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement

NCT05281588 | Completed

• 1 other identifier: Micro-osteoperforations
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Orthodontic Tooth Movement

Keywords

Micro-osteoperforations; Orthodontic incisors retraction

Outcome Measures

Primary Outcomes (2)

• Anteroposterior displacement of the upper incisors

  The anteroposterior displacement of the upper incisors was assessed on superimposed digital models through the distance of points on the incisal edge and palatal cervical margin of these teeth to a coronal reference plan created on the initial CBCT scan.

  Up to 4 months

• Space closure

  The space closure was assessed by the distance between the most menial point of the medial surface of the canine to the most distal point of the distal surface of the lateral incisor.

  Up to 4 months

Secondary Outcomes (3)

• First molars anchorage loss

  Up to 4 months

• Changes of the inclination of the central incisors

  Up to 4 months

• Changes of the length of the central incisors

  Up to 4 months

Study Arms (2)

Micro-osteoperforations

EXPERIMENTAL

Micro-osteoperforations- assisted upper incisors retraction

Procedure: Micro-osteoperforations

Control

NO INTERVENTION

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

Interventions

Micro-osteoperforations 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.

Also known as: MOP

Micro-osteoperforations

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pontifícia Universidade Católica de Minas Gerais: lead
• Case Western Reserve University: collaborator

Study Sites (1)

Pontifícia Universidade Católica de Minas Gerais

Belo Horizonte, Minas Gerais, 30535-610, Brazil

Location

Related Publications (1)

• Mordente CM, Dores LS, Oliveira DD, Palomo JM, Souki BQ, Soares RV. Third Palatal Rugae as Stable Landmarks for Intraoral Models' Superimposition in Extraction Cases: A Retrospective Cohort Study. Orthod Craniofac Res. 2025 Dec 25. doi: 10.1111/ocr.70078. Online ahead of print.

  PMID: 41445469 DERIVED

Study Officials

• Rodrigo V Soares, PhD

  Pontifícia Universidade Católica de Minas Gerais

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: February 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year
• Access Criteria: All researchers

Locations

BR (1)