Effects of Micro-osteoperforation on the Maxillary First Molar Distalization

Study Overview
=================
Brief Summary
-----------------
the study aimed to evaluate the effect of different types of Micro-osteoperforation on the rate of distal movement of maxillary first molars as a primary out come. Besides, it was aimed to study secondary effect on the first molars by evaluating root resorption, bone density, and level of the pain during performing the procedures.

Detailed Description
-----------------
in the study, investigators tried to evaluate two methods to accelerate tooth movement by comparing them with control group. the first method was to apply one-time micro-osteoperforation. the second method was to apply the micro-osteoperforation repeatedly till reaching the end of the phase one treatment.

Official Title
-----------------
The Effect of Single and Repeated Micro-osteoperforation on the Maxillary First Molar Distalization: A Randomized Controlled Trial

Conditions
-----------------
Accretions; Teeth

Intervention / Treatment
-----------------
* Procedure: Micro-osteoperforation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Space deficiency in the upper arch > 5 mm, and < 8 mm. Non-extraction lower arch. Full upper dentition up to the second molars. Third molar present in both sides, not yet erupted. Exclusion Criteria: Systemic disease or syndrome. Evidence of root resorption. Poor oral hygiene. Previous orthodontic treatment Evidence of bone loss. Active periodontal disease. Pregnant females. Presence of oral habits

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-center, prospective, single blinded, with 3 parallel arms, randomized clinical trial that had a 1:1:1 allocation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>the group underwent distalization, with no Micro-osteoperforation | |
| Experimental: Single MOP<br>the group underwent one time Micro-osteoperforation procedure | Procedure: Micro-osteoperforation<br>* flapless small punctures in the bone at direction of tooth movement to accelerate the movement.<br>|
| Experimental: repeated MOP<br>the group underwent monthly Micro-osteoperforation procedure | Procedure: Micro-osteoperforation<br>* flapless small punctures in the bone at direction of tooth movement to accelerate the movement.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of maxillary first molar distal movement | evaluation of the whole rate of distal movement of the first molar | through study completion, an average 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in length of maxillary first molars in mm. | the change in the lengths of roots of maxillary first molars in mm. | through study completion, an average 1 year | 
| bone density | bone density around the first molar | through study completion, an average 1 year | 
| pain perception questionnaire | evaluate the pain perception to the intervention | through study completion, an average 1 year |