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The primary aim of the current study was to evaluate three dimensionally, using digital models and cone beam computed tomography imaging, the effect of micro-osteoperforations on the rate of tooth movement in the first molar distalization.
The design of this randomized controlled clinical trial is a parallel group, two arms trial
Preparatory phase
Experimental phase
Follow up phase
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micro osteo-perforation side | Experimental | the patient will receive micro osteo-perforation in one side Computer generated random numbers will generated using Microsoft Office Excel sheet by a person who was not involved in the clinical trial. Because of the split mouth design, the right sides of patients will randomly be assigned to one of the two groups (MOPs or control). Then, the left sides will automatically be assigned to the alternative group. |
|
| no micro osteo-perforation side | No Intervention | the other side without micro osteo-perforation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micro osteo-perforation | Procedure | the patient will receive miniscrew micro osteo-perforation in one side every month with molar distalization and the other side the distalization without micro osteo-perforation |
| Measure | Description | Time Frame |
|---|---|---|
| rate of molar distalization | Incremental rate of molar distalization every month by intra oral scan superimposition | 6 months |
| total molar distalization distance by mm between T6 and T0 | Total distance moved by the molar after 6 months by intra oral scan superimposition and measure the linear difference in position 1st molar between T6 and T0 by mm | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of MOPs on Maxillary 1st molar tipping by degrees between T6 and T0 | comparing the pre- & post- distalization CBCT and measure the angular change in the 1st molar long axis tipping by degree between T6 and T0 | 6 months |
| The effect of MOPs on Maxillary 1st molar rotation by degrees between T6 and T0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Elsayed, PhD | Contact | 00201064111810 | mohamedessam4@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fatma Abdou, professor | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university | Recruiting | Cairo | Egypt |
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Subjects will receive MOPs randomly to either the left or right maxillary molar buccal alveolar regions. MOPs will be performed at the first day of the distalization treatment (T0) and will repeated every 2 months.
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The first assessor will perform the digital models & CBCT measurements blindly for each patient. The second assessor will perform the same measurements blindly to calculate the inter-observer error
comparing the pre- & post- distalization digital models and CBCT and measure the angular change in the 1st molar long axis rotation by degree between T6 and T0 |
| 6 months |
| The effect of MOPs on Maxillary 1st molar vertical movement by mm between T6 and T0 | comparing the pre- & post- distalization CBCT and measure the linear change in the 1st molar vertical position by mm between T6 and T0 | 6 months |
| The effect of MOPs on 1st molar root resorption level by mm between T6 and T0 | comparing the pre- & post- distalization CBCT and measure the amount of root resorption of 1st molar roots by mm between T6 and T0 | 6 months |
| Detecting any Pain or discomfort caused by the micro-osteoperforations using Numeric pain rating scale | using Numeric Pain Rating Scale filled by the patient with minimum value is zero and maximum value 10 (the higher score mean worse outcome) | 1 week |