Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement

Orthodontic Tooth Movement Clinical Trial

— MOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05281588
• Other study ID #: Micro-osteoperforations
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: March 2020

Study information

• Verified date: March 2022
• Source: Pontifícia Universidade Católica de Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Orthodontic Tooth Movement

Intervention

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.

Locations

Country	Name	City	State
Brazil	Pontifícia Universidade Católica de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Pontifícia Universidade Católica de Minas Gerais	Case Western Reserve University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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