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

Primary Purpose

Orthodontic Tooth Movement

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Micro-osteo-perforations
Sponsored by
Rehman Medical Institute - RMI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthodontic Tooth Movement focused on measuring Micro-osteo-perforations, orthodontic tooth movement, clinical trial

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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: Patients with any sort of systemic disease. Radiographic evidence of bone loss. History of periodontal therapy Active periodontal disease. Patients with a history of smoking of five years or more. Patients with active gingivitis and Caries. Attrition of canine cusp.

Sites / Locations

  • RMIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

3 MOPs group

1 MOP group

Arm Description

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.

the subjects under the split mouth intervention on the control side will undergo 1 micro-osteo-perforation in comparison to the experimental side.

Outcomes

Primary Outcome Measures

The rate of tooth movement (canine retraction)
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.

Secondary Outcome Measures

Pain associated with MOPs
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.

Full Information

First Posted
May 13, 2023
Last Updated
August 15, 2023
Sponsor
Rehman Medical Institute - RMI
Collaborators
Gandhara University
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1. Study Identification

Unique Protocol Identification Number
NCT05995509
Brief Title
The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement.
Acronym
MOPs
Official Title
The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rehman Medical Institute - RMI
Collaborators
Gandhara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Tooth Movement
Keywords
Micro-osteo-perforations, orthodontic tooth movement, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3 MOPs group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
1 MOP group
Arm Type
Experimental
Arm Description
the subjects under the split mouth intervention on the control side will undergo 1 micro-osteo-perforation in comparison to the experimental side.
Intervention Type
Procedure
Intervention Name(s)
Micro-osteo-perforations
Intervention Description
small perforations drilled in Alveolar bone, adjacent to site of tooth movement.
Primary Outcome Measure Information:
Title
The rate of tooth movement (canine retraction)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Pain associated with MOPs
Description
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.
Time Frame
In the surgery after the procedure is completed and just before the patient was sent home.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Patients with any sort of systemic disease. Radiographic evidence of bone loss. History of periodontal therapy Active periodontal disease. Patients with a history of smoking of five years or more. Patients with active gingivitis and Caries. Attrition of canine cusp.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javaid
Phone
03349590787
Email
asmjavaid@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sohrab Shaheed, FFDRCSI
Phone
03339327608
Email
s.shaheed@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Tajik, FCPS
Organizational Affiliation
Sardar Begum Dental College
Official's Role
Study Chair
Facility Information:
Facility Name
RMI
City
Peshawar
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RMI
Phone
03349590787
Email
asmjavaid@gmail.com
First Name & Middle Initial & Last Name & Degree
RMI

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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