NCT02473471

Micro-osteoperforations and Tooth Movement

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Jordan University of Science and Technology · Academic / Other
• Sex: All
• Age: 16 Years – 26 Years
• Healthy volunteers: Accepted

Summary

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

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)

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	Micro-osteoperforation	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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-06-16
• Last updated: 2017-11-28
• Results posted: 2017-11-22

Locations

1 site across 1 country: Jordan