Overview

This trial is active, not recruiting.

Condition malocclusion
Treatment micro-osteoperforation
Sponsor Jordan University of Science and Technology
Start date April 2015
End date December 2016
Trial size 39 participants
Trial identifier NCT02473471, JordanUST

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
micro-osteoperforation Selective alveolar decortication
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.
(No Intervention)
No intervention in the other side of maxilla (control side)

Primary Outcomes

Measure
The rate of tooth movement
time frame: within 3 months

Secondary Outcomes

Measure
Pain intensity
time frame: within 7 days after the intervention
Root resorption
time frame: At the start of canine retraction until close of space ( almost 3 months )
Pain interference
time frame: within 7 days after the intervention
Patient satisfaction
time frame: In 1,3,5,7 days after MOP application
Menstrual cycle
time frame: within 3 months

Eligibility Criteria

Male or female participants from 16 years up to 26 years old.

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

Additional Information

Official title Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial
Principal investigator Amal A Alkebsi, MClinDent
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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Jordan University of Science and Technology.