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Completed

NCT Number: NCT05281588

Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement

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

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Key information

Conditions

Orthodontic Tooth Movement

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontifícia Universidade Católica de Minas Gerais

Belo Horizonte, Minas Gerais, 30535-610, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: MOP

Primary outcomes

  1. Anteroposterior displacement of the upper incisors

    Time frame: 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.

  2. Space closure

    Time frame: 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 outcomes

  1. First molars anchorage loss

    Time frame: 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.

  2. Changes of the inclination of the central incisors

    Time frame: 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.

  3. Changes of the length of the central incisors

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pontifícia Universidade Católica de Minas Gerais

Other

Collaborators

  • Case Western Reserve University

Registry information

Official study title

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

Acronym: MOP

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 16, 2022
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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