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

Orthodontic Tooth Movement Clinical Trial

— MOPs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995509
• Other study ID #: CPSP/REU/DSG-2017-026-2176
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Rehman Medical Institute - RMI
• Contact: Javaid
• Phone: 03349590787
• Email: asmjavaid[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthodontic Tooth Movement

Intervention

Procedure:
• Micro-osteo-perforations
small perforations drilled in Alveolar bone, adjacent to site of tooth movement.

Locations

Country	Name	City	State
Pakistan	RMI	Peshawar

Sponsors (2)

Lead Sponsor	Collaborator
Rehman Medical Institute - RMI	Gandhara University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	In the surgery after the procedure is completed and just before the patient was sent home.