The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement.

Study Overview
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Brief Summary
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The objective of this split mouth trial is to compare mean canine retraction with one Micro-osteo-perforation (MOP) against three MOPs among Class II division I orthodontic patients after one month of intervention.

Detailed Description
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One of the main concerns for orthodontists and patients who seek orthodontic therapy is the prolonged treatment time. A commitment of about 18-24 months makes decision making difficult for many patients. The prolonged treatment time is also a potential factor leading to complications like white spot lesions, root resorption, gingivitis and periodontitis. Different techniques to speed up tooth movement have been used in orthodontics. Micro-osteo-perforations is one of the new ways to expedite tooth movement. Previous trials of MOP (Micro-osteo-perforations) to expedite tooth movement had certain shortcomings including the lack of details of randomization. Further studies with variation in the number and frequency of MOPs over a longer duration were recommended. It also raises a curiosity if reducing the number of MOPs would be equally effective in accelerating the canine retraction. Hence, the purpose of this split mouth trial was to investigate the effect of number of MOPs on the rate of canine retraction. The objective of this split mouth trial is to compare mean canine retraction with one MOP against three MOPs among Class II division I orthodontic patients after one month of intervention. STUDY DESIGN: Split-mouth parallel arm randomized control trial.

Official Title
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The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement: A Randomized Controlled Trial.

Conditions
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Orthodontic Tooth Movement

Intervention / Treatment
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* Procedure: Micro-osteo-perforations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All male and female patients in an age range of 12-25 years requiring bilateral first premolar extraction in maxillary arch. - Exclusion Criteria: Patients with any sort of systemic disease. Radiographic evidence of bone loss. History of periodontal therapy Active periodontal disease. Patients with a history of smoking of five years or more. Patients with active gingivitis and Caries. Attrition of canine cusp.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 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 |
| --- | --- |
| Active Comparator: 3 MOPs group<br>The subjects under a split mouth intervention on the experimental side will undergo 3 micro-osteo-perforations (creating small holes in the buccal cortical bone) to assess the rate of tooth movement. | Procedure: Micro-osteo-perforations<br>* small perforations drilled in Alveolar bone, adjacent to site of tooth movement.<br>|
| Experimental: 1 MOP group<br>the subjects under the split mouth intervention on the control side will undergo 1 micro-osteo-perforation in comparison to the experimental side. | Procedure: Micro-osteo-perforations<br>* small perforations drilled in Alveolar bone, adjacent to site of tooth movement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of tooth movement (canine retraction) | The canine retraction will be measured from a mid-palatine line drawn on the pre treatment and post MOP dental cast. Further perpendicular lines will be drawn towards the distal surface of canine and the mesial surface of the second premolar. The Canine retraction will be measured as the difference between the two lines measured in millimetres. The clinical significance will be set at 50% or more of the rate of canine retraction of the control side. | The movement of canines on both sides will be measured after 30 days of 150g of force application on the intervention and control side. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain associated with MOPs | The pain or discomfort to the patient will be assessed using a Baker's visual analogue scale on the control and the experimental sides. The scale will be calibrated in millimetres from 0-10 with 0 denoting no pain and 10 denoting worst pain possible. | In the surgery after the procedure is completed and just before the patient was sent home. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Micro-osteo-perforations, orthodontic tooth movement, clinical trial