MOP: Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement

Sponsor

Pontifícia Universidade Católica de Minas Gerais (Other)

Overall Status

Completed

CT.gov ID

NCT05281588

Collaborator

Case Western Reserve University (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Tooth Movement	Procedure: Micro-osteoperforations	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Control Upper incisors retraction not associated with any clinical intervention to accelerate tooth movement

Arm

Intervention/Treatment

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

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Anteroposterior displacement of the upper incisors [Up to 4 months]
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.
Space closure [Up to 4 months]
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.

Secondary Outcome Measures

First molars anchorage loss [Up to 4 months]
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.
Changes of the inclination of the central incisors [Up to 4 months]
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.
Changes of the length of the central incisors [Up to 4 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pontifícia Universidade Católica de Minas Gerais	Belo Horizonte	Minas Gerais	Brazil	30535-610

Sponsors and Collaborators

Pontifícia Universidade Católica de Minas Gerais
Case Western Reserve University

Investigators

Study Director: Rodrigo V Soares, PhD, Pontifícia Universidade Católica de Minas Gerais

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pontifícia Universidade Católica de Minas Gerais

ClinicalTrials.gov Identifier:

NCT05281588

Other Study ID Numbers:

Micro-osteoperforations

First Posted:

Mar 16, 2022

Last Update Posted:

Mar 18, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pontifícia Universidade Católica de Minas Gerais

Micro-osteoperforations

Orthodontic incisors retraction

Study Results

No Results Posted as of Mar 18, 2022