Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement

Study Overview
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Brief Summary
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This clinical trial evaluated the efficacy of micro osteoperforations in accelerating the retraction of maxillary incisors.

Detailed Description
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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.

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

Conditions
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Orthodontic Tooth Movement

Intervention / Treatment
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* Procedure: Micro-osteoperforations


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Micro-osteoperforations, Orthodontic incisors retraction