The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement. (MOPs)

August 15, 2023 updated by: Rehman Medical Institute - RMI

The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement: A Randomized Controlled Trial.

The objective of this split mouth trial is to compare mean canine retraction with one Micro-osteo-perforation (MOP) against three MOPs among Class II division I orthodontic patients after one month of intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

One of the main concerns for orthodontists and patients who seek orthodontic therapy is the prolonged treatment time. A commitment of about 18-24 months makes decision making difficult for many patients. The prolonged treatment time is also a potential factor leading to complications like white spot lesions, root resorption, gingivitis and periodontitis. Different techniques to speed up tooth movement have been used in orthodontics. Micro-osteo-perforations is one of the new ways to expedite tooth movement. Previous trials of MOP (Micro-osteo-perforations) to expedite tooth movement had certain shortcomings including the lack of details of randomization. Further studies with variation in the number and frequency of MOPs over a longer duration were recommended. It also raises a curiosity if reducing the number of MOPs would be equally effective in accelerating the canine retraction. Hence, the purpose of this split mouth trial was to investigate the effect of number of MOPs on the rate of canine retraction.

The objective of this split mouth trial is to compare mean canine retraction with one MOP against three MOPs among Class II division I orthodontic patients after one month of intervention.

STUDY DESIGN: Split-mouth parallel arm randomized control trial.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: All male and female patients in an age range of 12-25 years requiring bilateral first premolar extraction in maxillary arch.

-

Exclusion Criteria:

  1. Patients with any sort of systemic disease.
  2. Radiographic evidence of bone loss.
  3. History of periodontal therapy
  4. Active periodontal disease.
  5. Patients with a history of smoking of five years or more.
  6. Patients with active gingivitis and Caries.
  7. Attrition of canine cusp.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3 MOPs group
The subjects under a split mouth intervention on the experimental side will undergo 3 micro-osteo-perforations (creating small holes in the buccal cortical bone) to assess the rate of tooth movement.
Procedure: Micro-osteo-perforations
small perforations drilled in Alveolar bone, adjacent to site of tooth movement.
Experimental: 1 MOP group
the subjects under the split mouth intervention on the control side will undergo 1 micro-osteo-perforation in comparison to the experimental side.
Procedure: Micro-osteo-perforations
small perforations drilled in Alveolar bone, adjacent to site of tooth movement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of tooth movement (canine retraction)
Time Frame: The movement of canines on both sides will be measured after 30 days of 150g of force application on the intervention and control side.
The canine retraction will be measured from a mid-palatine line drawn on the pre treatment and post MOP dental cast. Further perpendicular lines will be drawn towards the distal surface of canine and the mesial surface of the second premolar. The Canine retraction will be measured as the difference between the two lines measured in millimetres. The clinical significance will be set at 50% or more of the rate of canine retraction of the control side.
The movement of canines on both sides will be measured after 30 days of 150g of force application on the intervention and control side.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain associated with MOPs
Time Frame: In the surgery after the procedure is completed and just before the patient was sent home.
The pain or discomfort to the patient will be assessed using a Baker's visual analogue scale on the control and the experimental sides. The scale will be calibrated in millimetres from 0-10 with 0 denoting no pain and 10 denoting worst pain possible.
In the surgery after the procedure is completed and just before the patient was sent home.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehman Medical Institute - RMI

Collaborators

Gandhara University

Investigators

  • Study Chair: Imran Tajik, FCPS, Sardar Begum Dental College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 13, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CPSP/REU/DSG-2017-026-2176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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