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

• Sponsor: Rehman Medical Institute - RMI (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05995509
• Collaborator: Gandhara University (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.4
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Tooth Movement	Procedure: Micro-osteo-perforations	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement: A Randomized Controlled Trial.
• Actual Study Start Date: Mar 21, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The rate of tooth movement (canine retraction) [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.

Secondary Outcome Measures

1. Pain associated with MOPs [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RMI	Peshawar		Pakistan

Sponsors and Collaborators

• Rehman Medical Institute - RMI
• Gandhara University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rehman Medical Institute - RMI
• ClinicalTrials.gov Identifier: NCT05995509
• Other Study ID Numbers: CPSP/REU/DSG-2017-026-2176
• First Posted: Aug 16, 2023
• Last Update Posted: Aug 16, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rehman Medical Institute - RMI: Micro-osteo-perforations; orthodontic tooth movement; clinical trial

Study Results

No Results Posted as of Aug 16, 2023