- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07399197
3-D Evaluation of Alveolar Bone Changes and Root Resorption After Traction of Buccally Displaced Maxillary Canines (BDMC)
Three-Dimensional Evaluation of Alveolar Bone Changes and Root Resorption After Orthodontic Traction of Unilateral Buccally Displaced Maxillary Canines Using Two Different Techniques: A Randomized Clinical Trial
This clinical study used CBCT images to investigate the alveolar bone changes and root resorption in unilateral buccally displaced maxillary canines and adjacent teeth before and after orthodontic traction of unilateral BDMCs.
The CBCT images will also be used to compare these changes to the normal contralateral side. The study outcome is to compare the 3-D changes in the alveolar bone and dental roots between the 2 interventional techniques (segmentalT-loop and piggyback NiTi traction) methods.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Buccally displaced eruptions of permanent maxillary canines occur in 0.8% to 5.2% of orthodontic cases. Patients are often motivated to request orthodontic treatment when they have crowded teeth and maxillary canines that come in buccally erupted.
The treatment of BDMC is challenging due to the limited labial alveolar bone and the potential risks of root resorption, bone loss, and gingival recession due to the movement of long and bulge roots, necessitating bodily movement with light and constant orthodontic force. The previous studies focused only on comparisons of root resorption, bone loss, and periodontal health before and after impacted canine traction. The previous studies on BDMC mainly included case reports that looked at various orthodontic traction methods. To our knowledge, no randomized clinical trial has been done to study the 3- D changes in the alveolar bone and root length after orthodontic traction of BDMCs.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fuad Luft Almutareb, Prf.
- Phone Number: 0967772275275
- Email: f.almotareb@su.edu.ye
Study Contact Backup
- Name: Mohammed A Al-Hababy, MSc
- Phone Number: 00967- 777771166
- Email: mohammed.al-hababi@su.edu.ye
Study Locations
-
-
Sana'a
-
Sanaa, Sana'a, Yemen, 00967
- Recruiting
- Sana'a University
-
Contact:
- Mohammed Abdullah Al-Hababy, MSc in Orthodontics
- Phone Number: 00967- 777771166
- Email: mohammed.al-hababi@su.edu.ye
-
Contact:
- Fuad Luft Almutareb, Prf.
- Phone Number: 00967- 772275275
- Email: f.almotareb@su.edu.ye
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Yemeni ethnic patients.
- Presence of unilateral BDMC.
- The presence of a properly positioned and normally erupted contralateral canine.
- Mild to moderate crowding.
- The need for fixed orthodontic treatment.
- No sagittal discrepancy
Exclusion Criteria:
- History of severe facial trauma.
- Previous orthodontic treatment.
- Presence of bilateral BDMC.
- Presence of developmental dental anomalies.
- Presence of facial syndromes and bone metabolism disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: T-loop
In patients randomized to the frictionless group, T-loops were fabricated using 0.017 X 0.025-inch TMA wire. The posterior leg of the T-loops will be inserted in the auxiliary tube of the first molar, and the anterior leg engaged the canine bracket. |
Firstly, only the BDMC will be bonded with a preadjusted edgewise bracket from the 0.022-in-slot MBT system and cementing the trans palatal arch. Canine traction will be carried out by ligating the segmental T loop of 0.016×0.022 TMA wire on the BDMC and inserting the other end of the T loop in the maxillary first permanent molar tube. The segmented T loop will be activated by 2 mm per month and tightened posteriorly to the tube of the first permanent molar for approximately 3 months to move the canine. Once the BDMC is in the proper site in the maxillary arch, all teeth in both maxillary and mandibular arches will be bonded with preadjusted edgewise brackets from the 0.022-in-slot MBT system. Leveling and alignment will start with engaging 0.014-in NiTi arch wires in both arches. |
|
Active Comparator: Piggyback double wire
In patients randomized to the piggyback double wire method, all teeth in both maxillary and mandibular arches will be bonded with preadjusted edgewise brackets from the 0.022- in-slot MBT system.
|
All teeth in both maxillary and mandibular arches will be bonded with preadjusted edgewise brackets from the 0.022- in-slot MBT system. Leveling and alignment will start with engaging 0.014-in NiTi arch wires in both arches, bypassing maxillary BDMC. The arch wire sequence will include 0.014-in NiTi, 0.016-inch NiTi, 0.016x0.022-inch NiTi. After the arches are properly aligned, the piggyback technique will be used on the maxillary arch, and the arch wire size will be increased to 0.016 x 0.016-inch stainless15 steel for the maxillary arch and ligating the accessory 0.012-inch NiTi round for BDMC traction. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change in the Alveolar Bone Thickness
Time Frame: From baseline (before orthodontic traction) to the completion of orthodontic traction (an average of 8 months)
|
The mean change in the alveolar bone thickness will be measured in millimeters (mm) using CBCT scans.
|
From baseline (before orthodontic traction) to the completion of orthodontic traction (an average of 8 months)
|
|
Mean Change in the Alveolar Bone Height
Time Frame: Baseline and Month 8
|
Alveolar bone height measured in millimeters (mm) using CBCT.
|
Baseline and Month 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change in Root Resorption
Time Frame: Baseline and Month 8
|
The rate of external root resorption in mm measured using CBCT scans.
|
Baseline and Month 8
|
|
Difference Between Two groups in Alveolar Bone Dimension Changes
Time Frame: Month 8 after the completion of canine traction.
|
Measuring the mean change in alveolar bone dimension (mm) between Segmental T loop and Piggyback Orthodontic traction techniques using CBCT.
|
Month 8 after the completion of canine traction.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammed A Al-Hababy, MSc, Sana'a University
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- OR:04/03/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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