Malocclusion; Displaced TeethBDMCNCT07399197
3-D Evaluation of Alveolar Bone Changes and Root Resorption After Traction of Buccally Displaced Maxillary Canines
A study testing T-loop and Piggyback double wire in people with Malocclusion; Displaced Teeth, run by Sana'a University at 1 site in Yemen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion; Displaced Teeth
- What is being tested?
- T-loop and Piggyback double wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteYemen
- Study dates
- 2 Mar 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site, 1 recruiting
- Recruiting
Sana'a University
Sanaa, Sana'a, 00967
Mohammed Abdullah Al-Hababy, MSc in Orthodontics, 00967- 777771166, mohammed.al-hababi@su.edu.ye
Fuad Luft Almutareb, Prf., 00967- 772275275, f.almotareb@su.edu.ye
About this study
Official title: 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.
Read the 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.
- Conditions
- Malocclusion; Displaced Teeth
- Being tested
- T-loop, Piggyback double wire
- Keywords
- Buccally Displaced Maxillary Canines, Alveolar Bone Changes, Root Resorption, Orthodontic Treatment
- Medical subject headings
- Malocclusion, Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-loopDevice
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.
Piggyback double wireDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| T-loop | Active comparator | 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. Receives: Device: T-loop |
| Piggyback double wire | Active comparator | 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. Receives: Device: Piggyback double wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in the Alveolar Bone Thickness
The mean change in the alveolar bone thickness will be measured in millimeters (mm) using CBCT scans.
Measured: From baseline (before orthodontic traction) to the completion of orthodontic traction (an average of 8 months)
Mean Change in the Alveolar Bone Height
Alveolar bone height measured in millimeters (mm) using CBCT.
Measured: Baseline and Month 8
Secondary outcomes (2)
Mean Change in Root Resorption
The rate of external root resorption in mm measured using CBCT scans.
Measured: Baseline and Month 8
Difference Between Two groups in Alveolar Bone Dimension Changes
Measuring the mean change in alveolar bone dimension (mm) between Segmental T loop and Piggyback Orthodontic traction techniques using CBCT.
Measured: Month 8 after the completion of canine traction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start2 Mar 2026
- Primary completion2 Aug 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion; Displaced TeethStudies 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
- This clinical trial will use a randomized design with equal allocation in a 1:1 ratio, blinding, and paralleling two groups. The study will compare the treatment outcomes between the segmental T-loop and the piggyback double wire traction techniques. The study will use CBCT images to evaluate the 3-D changes in the alveolar bone and root length of the unilateral BDMCs and adjacent teeth before and after orthodontic traction and compare them with the normal contralateral canines and adjacent teeth.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdullah Abdullah Al-Hababy, Sana'a University
- Investigators
- Mohammed A Al-Hababy, MSc, Principal investigator, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399197
- Sponsor's protocol ID
- OR:04/03/2025
- Acronym
- BDMC
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07399197
- Acronym / sponsor ID
- BDMC / OR:04/03/2025
- Conditions
- Malocclusion; Displaced Teeth
- Keywords
- Buccally Displaced Maxillary Canines, Alveolar Bone Changes, Root Resorption, Orthodontic Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 2 Aug 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This clinical trial will use a randomized design with equal allocation in a 1:1 ratio, blinding, and paralleling two groups. The study will compare the treatment outcomes between the segmental T-loop and the piggyback double wire traction techniques. The study will use CBCT images to evaluate the 3-D changes in the alveolar bone and root length of the unilateral BDMCs and adjacent teeth before and after orthodontic traction and compare them with the normal contralateral canines and adjacent teeth.
| Arm | Type | Receives |
|---|---|---|
| T-loop | Active comparator | Device: T-loopIn 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. |
| Piggyback double wire | Active comparator | Device: Piggyback double wireIn 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-loopFirstly, 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. | Device | T-loop |
| Piggyback double wireAll 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. | Device | Piggyback double wire |
Primary outcome
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.
Mean Change in the Alveolar Bone Height
Time frame: Baseline and Month 8
Alveolar bone height measured in millimeters (mm) using CBCT.
2 secondary outcomes
Mean Change in Root Resorption
Time frame: Baseline and Month 8
Difference Between Two groups in Alveolar Bone Dimension Changes
Time frame: Month 8 after the completion of canine traction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed A Al-Hababy, MSc principal investigator
Sana'a University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-loop and Piggyback double wire in people with Malocclusion; Displaced Teeth, run by Sana'a University at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A Al-Hababy, MSc (00967- 777771166, mohammed.al-hababi@su.edu.ye), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.