Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement (MOP)

Effects of Micro-osteoperforations on the Upper Incisors' Retraction: a Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Orthodontic Tooth Movement
• Intervention / Treatment: Procedure: Micro-osteoperforations

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30535-610
      • Pontifícia Universidade Católica de Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Upper incisors retraction not associated with any clinical intervention to accelerate tooth movement
Experimental: Micro-osteoperforations; Micro-osteoperforations- assisted upper incisors retraction	Procedure: 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.; Other Names: MOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
First molars anchorage loss	The first molars anchorage loss was assessed on superimposed digital models through the distance of a point on the mesiobuccal cuspid to a coronal reference plan created on the initial CBCT scan.	Up to 4 months
Changes of the inclination of the central incisors	The initial and final CBCT were superimposed by the "voxel-based method" in the Dolphin Imaging software (Chatsworth, CA, USA), using the cranial base as reference. The inclination of the central incisors was then assessed by means of the angle formed by the long axis of each central incisor in the initial and final CBCT.	Up to 4 months
Changes of the length of the central incisors	The initial and final length of the central incisors were measured by creating a 2D line, passing through the lowest point of the incisal edge and the highest point of the root apex. To perform these measurements, a sagittal cut was used in which the longest length of these teeth was seen.	Up to 4 months

Collaborators and Investigators

• Sponsor: Pontifícia Universidade Católica de Minas Gerais
• Collaborators: Case Western Reserve University
• Investigators: Study Director: Rodrigo V Soares, PhD, Pontifícia Universidade Católica de Minas Gerais

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Micro-osteoperforations; Orthodontic incisors retraction
• Other Study ID Numbers: Micro-osteoperforations

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research can be shared with others researchers.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: All researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No