MalocclusionBMU/2026/8506NCT07879066
Evaluation of Corticotomy-Assisted Canine Retraction Rate
A study testing Experimental: Corticotomy¬-Assisted Canine Retraction in people with Malocclusion and Corticotomy, run by Tanzila Rafique at 1 site in Bangladesh.
Trial summary
The goal of this split-mouth randomized clinical trial is to evaluate the effectiveness of corticotomy on maxillary canine retraction rate compared to conventional orthodontic techniques. Each participant acts as their own control. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Corticotomy, Canine Retraction
- What is being tested?
- Experimental: Corticotomy¬-Assisted Canine Retraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBangladesh
- Study dates
- 8 Aug 2026to 8 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants who need both maxillary first molar extractions for orthodontic treatment.
- Class Ⅰ (Bimaxillary proclination), Class Ⅱ division 1 malocclusion.
- Participants with full permanent dentition present (excluding 3rd molar).
- Participants with good general health conditions and oral hygiene status.
- The age range of the patients will be 16 years to 25 years.
- Sex of the participants will be male, female, or third gender.
- The treatment plan of maximum anchorage value preservation used mini-implant anchorage during retraction of teeth to obtain good esthetics and correct the molar relationship.
- No previous orthodontic treatment.
Who cannot join
- Medically compromised patients with uncontrolled diabetes mellitus and compromised immune systems.
- Participants taking medications that alter bone metabolism like bisphosphonates, nonsteroidal anti-inflammatory drugs (NSAIDs), and on long-term corticosteroids.
- Vitamin D deficiency.
- Cleft lip /palate, craniofacial syndrome or facial asymmetry.
- Severe class Ⅲ malocclusion.
- Pregnant women.
- Smoker.
- Non-compliant patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
Bangladesh Medical University (BMU), Dhaka,1000
Dhaka, Bangladesh, 1000
About this study
Official title: Title: Evaluation of Corticotomy-Assisted Canine Retraction Rate: A Split-Mouth Randomized Clinical Trial.
The goal of this split-mouth randomized clinical trial is to evaluate the effectiveness of corticotomy on maxillary canine retraction rate compared to conventional orthodontic techniques. Each participant acts as their own control. After bilateral maxillary first premolar extractions, one quadrant is randomly assigned to receive corticotomy before retraction, while the contralateral quadrant undergoes standard orthodontic retraction without corticotomy.
Read the detailed description
The goal of this split-mouth randomized clinical trial is to evaluate the effectiveness of corticotomy on maxillary canine retraction rate compared to conventional orthodontic techniques. The main question it aims to answer is Does corticotomy-assisted canine retraction accelerate the rate of tooth movement compared to conventional canine retraction methods? Researchers will evaluate the rate of canine retraction, root resorption, bone density, and pocket depth after corticotomy during the canine retraction phase.
Participants will:
- Receive fixed orthodontic treatment using a pre-adjusted edgewise appliance system (Roth, 0.018-inch slot).
- Undergo bilateral maxillary first premolar extractions indicated for orthodontic space closure.
- Undergo a corticotomy (vertical buccal cortical plate cuts distal to the canine root) at the extraction appointment on one randomly assigned maxillary side (Experimental side).
- Receive conventional canine retraction with no corticotomy on the contralateral maxillary side (Control side).
- Have titanium mini-implants (Vector TAS, 1.4 × 8.0 mm) placed bilaterally between the second premolar and first molar for anchorage.
- Undergo bilateral canine retraction initiated with standardized force (150 gm elastomeric power chain) on a rigid 0.016 × 0.022-inch stainless steel working archwire.
- Be evaluated at baseline and every 3 months over a 6-month follow-up period to measure canine retraction rate, root resorption, and bone density via CBCT.
- Conditions
- Malocclusion, Corticotomy, Canine Retraction, Orthodontic Tooth Movement, Split-mouth Design, Bilateral Maxillary 1st Premolar Extraction
- Being tested
- Experimental: Corticotomy¬-Assisted Canine Retraction, Active Comparator / Control: Conventional Canine Retraction
- Keywords
- Corticotomy, Canine retraction, Accelerating tooth movement, regional acceleratory phenomenon (RAP)
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Corticotomy¬-Assisted Canine RetractionProcedure or surgery
Corticotomy will be performed on one maxillary quadrant before initiating standardized canine distalization.
Active Comparator / Control: Conventional Canine RetractionProcedure or surgery
Conventional canine retraction will be performed on the contralateral quadrant without corticotomy under identical orthodontic mechanics.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Corticotomy¬-Assisted Canine Retraction | Experimental | Corticotomy will be performed on one maxillary quadrant before initiating standardized canine distalization. Receives: Procedure: Experimental: Corticotomy¬-Assisted Canine Retraction; Procedure: Active Comparator / Control: Conventional Canine Retraction |
| Active Comparator / Control: Conventional Canine Retraction | Active comparator | Conventional canine retraction will be performed on the contralateral quadrant without corticotomy under identical orthodontic mechanics. Receives: Procedure: Experimental: Corticotomy¬-Assisted Canine Retraction; Procedure: Active Comparator / Control: Conventional Canine Retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of maxillary canine retraction
Linear distal movement of the maxillary canine measured on CBCT scans relative to a fixed anatomical landmark (e.g., the cusp tip, the center of the tooth (midpoint of the line joining the cusp tip and root apex), and the root apex) to compare the corticotomy-assisted side with the conventional side.
Measured: 6 months
Secondary outcomes (5)
Overall rate of maxillary canine retraction
- A frontal reference plane (FP) was constructed to the mid-sagittal and horizontal planes, passing through the incisive foramen and the long axis of the canine.
- Three landmarks identified on each CBCT volume: the cusp tip, the center of the tooth, and the root apex.
- The perpendicular distance from each of these three landmarks to the FP measured at both experimental and control sides.
- The amount of retraction at the cusp tip, center, and root apex calculated as the difference in distdistance-to-FP between successive time point and across the full retraction period.
Measured: Baseline to Post-retraction (6months)
Comparison of amount of canine root resorption between the corticotomy- assisted side and the conventional side.
-Root resorption was calculated (in mm) as the difference in canine length, from cusp tip to root apex, between the pre- and post-retraction CBCTs.
Measured: Baseline to Post-retraction (6months)
The rate of retraction at each landmark
The rate of retraction at each landmark was calculated by dividing the amount of movement by the time elapsed (mm per month).
Measured: Baseline to Post-retraction (6months)
Measurement of bone density between the corticotomy-assisted side and the conventional side.
Bone density was measured between the corticotomy-assisted side and the conventional side over six months by sequential CBCT scans(with the same field of view and the same voxel resolution) taken at T0 (baseline), T1 (3 months), and T2 (6 months).
Measured: Baseline to Post-retraction (6months)
Measurement and comparison of the pocket depth of the canine(in mm) between the corticotomy-assisted and the conventional side.
Pocket depth of the canine was measured between the corticotomy-assisted side and the conventional side by periodontal probing at T0 (baseline), T1 (3 months), and T2 (6 months).
Measured: Baseline to Post-retraction (6months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start8 Aug 2026
- Primary completion8 Aug 2027 (estimated)
- Study completion8 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant acts as their own control. After bilateral maxillary first premolar extractions, one quadrant is randomly assigned to receive corticotomy before retraction, while the contralateral quadrant undergoes standard orthodontic retraction without corticotomy.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanzila Rafique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tanzila Rafique, Bangladesh Medical University
- Investigators
- Mahmood Sajedeen, BDS,FCPS, Study director, Bangladesh Medical University (BMU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879066
- Sponsor's protocol ID
- BMU/2026/8506
- Acronym
- BMU/2026/8506
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No