Micro-osteoperforations and Tooth Movement

Study Overview
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Brief Summary
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The purpose of this study is determine the effect the Microosteoperforation (MOPs) using the miniscrew on the rate tooth movement. Moreover, measurement of the level of the pain and pain's interference, the level of satisfaction and comfort using this protocol. Finally root resorption associate with this technique will be evaluated.

Detailed Description
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This study will be randomized, split mouth design controlled trial with a 1:1 allocation ratio. One resident (A.A), calibrated by the main supervisor (S.M), will be reliable for recruiting the subjects, undertaking the orthodontic treatment under the supervision. The eligibility of the cases will be reevaluated by main supervisor (E.M) before the start of treatment. Split mouth design will be utilized with MOPs that will be randomly assigned to the patients' left or right sides to eliminate the possibility of uneven occlusal forces because of habitual occlusion predominantly on 1 side and also the eliminate the biological variability between subjects. The allocation sequence will be concealed from the researcher (A.A) enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes with the participant's the name and date of birth are written before the intervention. Allocation concealment seeks to prevent selection bias, protects the assignment sequence until allocation. A Ethical approval will be granted by Jordan University of science and technology research center, and permission will be given at postgraduate dental clinics at Jordan University of science and technology, Irbid, Jordan. We hypothesized that 50% increased in rate of tooth movement in MOP group would produce a clinically significant difference. The sample size was calculated depend on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups with 50% of acceleration rate of tooth movement, the power analysis yields a total sample size estimate of 44 samples at a conventional alpha-level (p = 0.05) and desired power (1 - β err prob) of 0.90, yielding 22 samples per group (means 22 patients that represent 22 MOP group and 22 Control group). Assuming an overall attrition rate of 15%, initial recruitment should target a total of 55 samples with 18 patients per group. All calculations were performed with the computer application G-Power (Erdfelder et al., 1996)

Official Title
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Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Micro-osteoperforation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female between 16 to 26 years old Class II Division 1 malocclusion or bimaxillary protrusion Average Lower facial height and Mandibular plane angle No systemic disease Healthy periodontal condition Non smoker Probing depth less than 4 mm in all teeth Exclusion Criteria: Long-term use of any Medication Poor oral hygiene Low and high angle cases Systemic disease Evidence of bone loss Active periodontal disease Smoker Probing depth more than 4 mm in all teeth Cephalometric analysis of the included subjects was performed at baseline including Sella-Nasion to A Point Angle (SNA): Measure Description: Sella-Nasion-A point (SNA) indicates the horizontal position of the maxilla relative to the cranial base. Sella-Nasion to B Point Angle (SNB): Sella-Nasion-B point (SNB) indicates the horizontal position of the mandible relative to the cranial base. A point to B Point Angle (ANB): A point- Nasion-B point (ANB) indicates the skeletal relationship between the maxilla and mandible. Maxillary mandibular plane angle (MM): The angle formed between the Maxillary Plane and Mandibular Plane. Maxillary Plane is the plane demonstrated by a line through the anterior and posterior nasal spines.A mandibular plane is a plane demonstrated by a line through the gonion and menton. Lower anterior facial height(LAFH) Upper incisor inclination: The angle between the maxillary plane and the axis of the maxillary incisors.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 26 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOP side<br>Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine. | Device: Micro-osteoperforation<br>* Three Micro-osteoperforation (MOPs) will be performed distal to canine by Mini screw. Before the application of the MOPs, Patient will be asked to wash their mouth twice by chorhexidine for 1 minute.<br>* Other names: Selective alveolar decortication;|
| No Intervention: control side<br>No intervention in the other side of maxilla (control side) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D Digital Model Measurements of Canine Rate of Tooth Movement | The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines. | Baseline to 1st month | 
| 3D Digital Model Measurements of Canine Rate of Tooth Movement | The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines. | Baseline to 2nd month | 
| 3D Digital Model Measurements of Canine Rate of Tooth Movement | The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines. | Baseline to 3rd month | 
| Intra Oral Measurements of Canine Rate of Tooth Movement | Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months. | Baseline to 1st month | 
| Intra Oral Measurements of Canine Rate of Tooth Movement | Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months. | Baseline to 2nd month | 
| Intra Oral Measurements of Canine Rate of Tooth Movement | Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months. | Baseline to 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root Resorption | It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period | Baseline to 3rd month | 
| Pain Intensity | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain. | within 7 days after the intervention | 
| Pain Interference /Pain During Eating? | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain. | within 7 days after the intervention | 
| Pain Interference /Pain Interrupted Sleep | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain. | within 7 days after the intervention | 
| Pain Interference /Swelling of the Surgical Side | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no swelling and 10 = worst swelling. | within 7 days after the intervention | 
| Pain Interference /Discomfort | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no discomfort and 10 = worst discomfort. | within 7 days after the intervention | 
| Patient Satisfaction | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = unsatisfied and 10 = most satisfaction. | After 7 days of MOP application | 
| Menstrual Cycle | the relationship between the rate of tooth movement and Menstrual cycle | within 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Micro-Osteoperforation (MOPs), regional acceleratory phenomenon (RAP), Malocculsion