- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07458139
Comparison of Root Resorption in Modified Corticotomy-Assisted and Conventional Canine Retraction (MCA-CR)
Comparison of External Apical Root Resorption in Modified Corticotomy-Assisted and Conventionally Retracted Maxillary Canines Using Frictionless T-Loop Mechanics: A Randomized Controlled Clinical Trial
Study Overview
Status
Detailed Description
External apical root resorption is a known complication of orthodontic treatment and may be influenced by the magnitude and duration of orthodontic force. Methods that accelerate tooth movement may reduce overall treatment time and potentially influence the extent of root resorption.
Corticotomy-assisted orthodontics is based on the regional acceleratory phenomenon, which enhances bone remodeling and facilitates tooth movement. Modified corticotomy techniques involve limited surgical injury to the cortical bone to stimulate accelerated movement while minimizing postoperative morbidity. Frictionless mechanics using T-loops allow controlled canine retraction with reduced frictional resistance between the bracket and archwire.
This single-center randomized controlled clinical trial will enroll 60 patients aged 12 to 30 years who require bilateral extraction of maxillary first premolars as part of orthodontic treatment. Participants will be randomly allocated in a 1:1 ratio to:
Group A: Modified corticotomy-assisted canine retraction with frictionless T-loop mechanics Group B: Conventional frictionless T-loop canine retraction
All participants will be treated using 0.022 × 0.028-inch preadjusted edgewise appliances. Standardized T-loop activation delivering controlled force will be performed at three-week intervals until canine retraction is completed.
External apical root resorption will be assessed by measuring linear changes in root length from the canine cusp tip to the root apex on calibrated pre- and post-retraction panoramic radiographs using digital measurement software. The primary outcome measure will be the mean change in root length between baseline and post-retraction assessments. Statistical analysis will compare the magnitude of root resorption between the two groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Menal Khurshid, BDS
- Phone Number: 0333-5303397
- Email: menal.15@iideas.edu.pk
Study Contact Backup
- Name: Prof. Dr. Haroon Shahid Qazi, BDS, MS, MCPS (HPE),
- Phone Number: 0300-5001774
- Email: haroon77@gmail.com
Study Locations
-
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Federal
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Islamabad, Federal, Pakistan, 45720
- Islamabad Dental Hospital
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Contact:
- Menal Khurshid, BDS
- Phone Number: 0333-5303397
- Email: menal.15@iideas.edu.pk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 12-30 years requiring canine retraction into maxillary first premolar extraction spaces
- Patients with normal vertical skeletal pattern (mandibular plane angle 32° ± 5°)
- Patients with healthy periodontium
Exclusion Criteria:
- Syndromic patients
- Patients with systemic conditions requiring long-term medication affecting orthodontic tooth movement (e.g., NSAIDs, bisphosphonates, anticonvulsants)
- Mixed dentition cases
- Patients with pre-existing root resorption
- Patients who fail to attend scheduled appointments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Modified Corticotomy Assisted Canine Retraction
Description: Participants will undergo modified corticotomy procedure followed by canine retraction using frictionless T-loop mechanics after extraction of maxillary first premolars. Intervention:
|
A surgical procedure in which a buccal flap is elevated and two vertical corticotomy cuts are made in the maxillary cortical bone adjacent to the extraction site to accelerate orthodontic tooth movement.
|
|
Active Comparator: Conventional T-loop Canine Retraction
Description: Participants will undergo conventional canine retraction using frictionless T-loop mechanics without any surgical intervention after extraction of maxillary first premolars. Intervention: Frictionless T-loop canine retraction. |
Orthodontic space closure using 17×25 TMA T-loops activated to deliver approximately 200 g of force for frictionless canine retraction into maxillary first premolar extraction spaces.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Loss of Canine Root Length (mm)
Time Frame: - Before retraction (baseline) - From baseline to completion of canine retraction (approximately 4-6 months)
|
External apical root resorption measured as the difference in root length (in millimeters) from canine cusp tip to root apex on calibrated pre-treatment and post-retraction OPG radiographs using ViewBox software.
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- Before retraction (baseline) - From baseline to completion of canine retraction (approximately 4-6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Root Width at Mesial and Distal Apex (mm)
Time Frame: From baseline to completion of canine retraction (approximately 4-6 months)
|
Difference in mesial and distal root width measured 1 mm short of the root apex on calibrated OPG radiographs before and after canine retraction.
|
From baseline to completion of canine retraction (approximately 4-6 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of External Apical Root Resorption According to Sharpe Classification
Time Frame: At completion of canine retraction (approximately 4-6 months)
|
SHARPE ET AL. CLASSIFICATION OF EXTERNAL ROOT RESORPTION 0 = No apical root resorption
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At completion of canine retraction (approximately 4-6 months)
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Collaborators and Investigators
Investigators
- Study Chair: Prof. Dr. Haroon Shahid Qazi, BDS, MS, MCPS (HPE), Islamabad Medical & Dental Hospital
Publications and helpful links
General Publications
- Hatrom AA, Zawawi KH, Al-Ali RM, Sabban HM, Zahid TM, Al-Turki GA, Hassan AH. Effect of piezocision corticotomy on en-masse retraction. Angle Orthod. 2020 Sep 1;90(5):648-654. doi: 10.2319/092719-615.1.
- Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
- Sondeijker CFW, Lamberts AA, Beckmann SH, Kuitert RB, van Westing K, Persoon S, Kuijpers-Jagtman AM. Development of a clinical practice guideline for orthodontically induced external apical root resorption. Eur J Orthod. 2020 Apr 1;42(2):115-124. doi: 10.1093/ejo/cjz034.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IDH123
- IDH-ORTHO-2026 (Other Identifier: Islamabad Medical & Dental College)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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