The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement.
MOPs
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2023
CompletedFirst Submitted
Initial submission to the registry
May 13, 2023
CompletedFirst Posted
Study publicly available on registry
August 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedAugust 16, 2023
August 1, 2023
1.2 years
May 13, 2023
August 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Pain associated with MOPs
In the surgery after the procedure is completed and just before the patient was sent home.
Study Arms (2)
3 MOPs group
ACTIVE COMPARATORThe 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.
1 MOP group
EXPERIMENTALthe subjects under the split mouth intervention on the control side will undergo 1 micro-osteo-perforation in comparison to the experimental side.
Interventions
small perforations drilled in Alveolar bone, adjacent to site of tooth movement.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rehman Medical Institute - RMIlead
- Gandhara Universitycollaborator
Study Sites (1)
RMI
Peshawar, Pakistan
Study Officials
- STUDY CHAIR
Imran Tajik, FCPS
Sardar Begum Dental College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2023
First Posted
August 16, 2023
Study Start
March 21, 2023
Primary Completion
May 31, 2024
Study Completion
June 1, 2024
Last Updated
August 16, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share