MalocclusionNCT07645417
Maxillary Canine Retraction Using Stainless Steel and Titanium-molybdenum Alloy Wires in TAD-supported Segmental Mechanics
A study testing A titanium-molybdenum alloy reverse-closing loop and A stainless steel reverse closing loop in people with Malocclusion and Canine Retraction, run by Tanzila Rafique at 1 site in Bangladesh.
Trial summary
The goal of this randomized clinical study is to compare the effectiveness of stainless steel (SS) and titanium-molybdenum alloy (TMA) wires for maxillary canine retraction using TAD-supported segmental mechanics. Read more about this study
- Who is it for?
- Ages 15 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Canine Retraction, Orthodontics
- What is being tested?
- A titanium-molybdenum alloy reverse-closing loop and A stainless steel reverse closing loop
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jul 2025to 1 Dec 2026
- 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 15 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants aged 15 to 35 years.
- Both male and female participants.
- Patients with all permanent teeth present, excluding third molars.
- Patients requiring extraction of both maxillary first premolars
- Patients with Class I or Class II molar relationship requiring maximum anchorage.
- Patients already undergoing fixed orthodontic treatment with a 0.018-inch Roth preadjusted appliance system.
- Maxillary canines aligned, symmetrical, and upright before the study.
- Patients in the leveling and alignment stage before canine retraction.
Who cannot join
- Missing or absent upper premolars.
- Previous orthodontic, orthognathic or reconstructive treatment.
- Systemic disease contraindicating dental implant placement.
- Use of systemic drugs or presence of systemic illness.
- Compromised periodontal condition.
- Use of anti-inflammatory therapy.
- Smokers.
- Pregnant female participants.
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, 1000
About this study
Official title: Comparative Evaluation of Maxillary Canine Retraction Using Stainless Steel and Titanium-molybdenum Alloy Wires in TAD-supported Segmental Mechanics
The goal of this randomized clinical study is to compare the effectiveness of stainless steel (SS) and titanium-molybdenum alloy (TMA) wires for maxillary canine retraction using TAD-supported segmental mechanics. The main question it aims to answer is:
Which wire material, stainless steel or titanium-molybdenum alloy, provides better outcomes in maxillary canine retraction when used with TAD-supported segmental mechanics? Researchers will compare SS reverse-closing loops with TMA reverse-closing loops to evaluate differences in the rate of canine retraction and canine angulation changes during orthodontic space closure.
Read more
Participants will:
- Receive mini-implants/TADs on both sides of the maxillary arch.
- Receive a stainless steel reverse-closing loop on one side and a TMA reverse-closing loop on the contralateral side.
- Receive the same standardized force of 150 g on both sides.
- Visit the clinic every 4 weeks for a total duration of 4 months.
- Undergo OPG radiographs before retraction and after the 4-month study period to assess canine angulation.
Read the detailed description
Background: Canine retraction is vital in orthodontic treatment, especially in first premolar extraction cases. Stainless steel (SS) and titanium-molybdenum alloy (TMA) wires are two most commonly used materials in segmental canine retraction with loop mechanics. Temporary anchorage devices (TADs), provide absolute anchorage.
Objective: To assess and compare maxillary canine retraction using SS and TMA wire in TAD-supported segmental mechanics.
Materials and Methods: After taking IRB approval, informed consent and assent a randomized clinical study will be conducted with 16 participants aged 15 to 35 years who require maxillary 1st premolar extraction on both sides to alleviate crowding or protrusion at Orthodontics department in Bangladesh Medical University (BMU). Each participant will receive a TAD on the same anatomic location with reverse closing loop (RCL) of SS wire 0.016 × 0.022" on one side and RCL of TMA wire 0.016 × 0.022" on contralateral side. Same 150 g force will be standardized with Dontrix gauge for both side. Rate of canine retraction will be measured intraorally with a digital slide caliper at four-week intervals for a total of four months. Canine angulation will be measured in OPG before retraction and after four months study period.
Statistical Analysis Plan: Data normality will be tested to select parametric or non-parametric analyses with P value <0.05 as significant. All the analyses will be performed using SPSS (version 30.0, IBM, New York, USA).
Expected outcome: TMA wire other than SS wire may be more effective in maxillary canine retraction from TAD-supported segmental mechanics providing scientific rationale for material choice.
- Conditions
- Malocclusion, Canine Retraction, Orthodontics, Tooth Movement Techniques, Anchorage Planning
- Being tested
- A titanium-molybdenum alloy reverse-closing loop, A stainless steel reverse closing loop
- Keywords
- Maxillary canine retraction, Orthodontic anchorage, Segmental mechanics, Stainless steel wire, TMA wire, Reverse closing loop, TAD, Canine angulation
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A titanium-molybdenum alloy reverse-closing loopProcedure or surgery
A titanium-molybdenum alloy reverse-closing loop will be placed on one side of the maxillary arch, and a stainless steel reverse-closing loop will be placed on the contralateral side of the maxillary arch and activated with a 150 g force to retract the canine.
A stainless steel reverse closing loopProcedure or surgery
A titanium-molybdenum alloy reverse-closing loop will be placed on one side of the maxillary arch, and a stainless steel reverse-closing loop will be placed on the contralateral side of the maxillary arch and activated with the same 150 g force for canine retraction.
| Study group | Role | What they receive |
|---|---|---|
| A titanium-molybdenum alloy reverse closing loop | Active comparator | A titanium-molybdenum alloy reverse-closing loop will be placed on one side of the maxillary arch and activated with 150 g force for canine retraction. Receives: Procedure: A titanium-molybdenum alloy reverse-closing loop; Procedure: A stainless steel reverse closing loop |
| A stainless steel reverse closing loop | Active comparator | A stainless steel reverse-closing loop will be placed on the contralateral side of the maxillary arch and activated with the same 150 g force to retract the canine. Receives: Procedure: A titanium-molybdenum alloy reverse-closing loop; Procedure: A stainless steel reverse closing loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the rate of maxillary canine retraction using stainless steel and TMA reverse-closing loops in TAD-supported segmental mechanics over 4 months.
The rate of maxillary canine retraction will be compared using stainless steel and TMA reverse-closing loops in TAD-supported segmental mechanics.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jul 2025
- Primary completion1 Aug 2026
- Study completion1 Dec 2026 (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
- Split-mouth randomized clinical study
- Masking
- None (open label)
- Enrolment
- 16 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 UNivbersity (BMU), Dhaka-1000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645417
- Sponsor's protocol ID
- BMU/2025/17099
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality and privacy will be preserved by utilizing unique identifying codes instead of personal identifiers
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Maxillary Canine Retraction Using Stainless Steel and Titanium-molybdenum Alloy Wires in TAD-supported Segmental Mechanics
- ClinicalTrials.gov ID
- NCT07645417
- Acronym / sponsor ID
- BMU/2025/17099
- Conditions
- Malocclusion, Canine Retraction, Orthodontics, Tooth Movement Techniques, Anchorage Planning
- Keywords
- Maxillary canine retraction, Orthodontic anchorage, Segmental mechanics, Stainless steel wire, TMA wire, Reverse closing loop, TAD, Canine angulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Tanzila RafiqueUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Jun 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.
The goal of this randomized clinical study is to compare the effectiveness of stainless steel (SS) and titanium-molybdenum alloy (TMA) wires for maxillary canine retraction using TAD-supported segmental mechanics. The main question it aims to answer is:
Which wire material, stainless steel or titanium-molybdenum alloy, provides better outcomes in maxillary canine retraction when used with TAD-supported segmental mechanics? Researchers will compare SS reverse-closing loops with TMA reverse-closing loops to evaluate differences in the rate of canine retraction and canine angulation changes during orthodontic space closure.
Participants will:
- Receive mini-implants/TADs on both sides of the maxillary arch.
- Receive a stainless steel reverse-closing loop on one side and a TMA reverse-closing loop on the contralateral side.
- Receive the same standardized force of 150 g on both sides.
- Visit the clinic every 4 weeks for a total duration of 4 months.
- Undergo OPG radiographs before retraction and after the 4-month study period to assess canine angulation.
Detailed description
Background: Canine retraction is vital in orthodontic treatment, especially in first premolar extraction cases. Stainless steel (SS) and titanium-molybdenum alloy (TMA) wires are two most commonly used materials in segmental canine retraction with loop mechanics. Temporary anchorage devices (TADs), provide absolute anchorage.
Objective: To assess and compare maxillary canine retraction using SS and TMA wire in TAD-supported segmental mechanics.
Materials and Methods: After taking IRB approval, informed consent and assent a randomized clinical study will be conducted with 16 participants aged 15 to 35 years who require maxillary 1st premolar extraction on both sides to alleviate crowding or protrusion at Orthodontics department in Bangladesh Medical University (BMU). Each participant will receive a TAD on the same anatomic location with reverse closing loop (RCL) of SS wire 0.016 × 0.022" on one side and RCL of TMA wire 0.016 × 0.022" on contralateral side. Same 150 g force will be standardized with Dontrix gauge for both side. Rate of canine retraction will be measured intraorally with a digital slide caliper at four-week intervals for a total of four months. Canine angulation will be measured in OPG before retraction and after four months study period.
Statistical Analysis Plan: Data normality will be tested to select parametric or non-parametric analyses with P value <0.05 as significant. All the analyses will be performed using SPSS (version 30.0, IBM, New York, USA).
Expected outcome: TMA wire other than SS wire may be more effective in maxillary canine retraction from TAD-supported segmental mechanics providing scientific rationale for material choice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-mouth randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| A titanium-molybdenum alloy reverse closing loop | Active comparator | Procedure: A titanium-molybdenum alloy reverse-closing loop, Procedure: A stainless steel reverse closing loopA titanium-molybdenum alloy reverse-closing loop will be placed on one side of the maxillary arch and activated with 150 g force for canine retraction. |
| A stainless steel reverse closing loop | Active comparator | Procedure: A titanium-molybdenum alloy reverse-closing loop, Procedure: A stainless steel reverse closing loopA stainless steel reverse-closing loop will be placed on the contralateral side of the maxillary arch and activated with the same 150 g force to retract the canine. |
Who may qualify
- Ages
- 15 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Participants aged 15 to 35 years.
- Both male and female participants.
- Patients with all permanent teeth present, excluding third molars.
- Patients requiring extraction of both maxillary first premolars
- Patients with Class I or Class II molar relationship requiring maximum anchorage.
Key exclusion criteria (8 listed)
- Missing or absent upper premolars.
- Previous orthodontic, orthognathic or reconstructive treatment.
- Systemic disease contraindicating dental implant placement.
- Use of systemic drugs or presence of systemic illness.
- Compromised periodontal condition.
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 |
|---|---|---|
| A titanium-molybdenum alloy reverse-closing loopA titanium-molybdenum alloy reverse-closing loop will be placed on one side of the maxillary arch, and a stainless steel reverse-closing loop will be placed on the contralateral side of the maxillary arch and activated with a 150 g force to retract the canine. | Procedure or surgery | A stainless steel reverse closing loop, A titanium-molybdenum alloy reverse closing loop |
| A stainless steel reverse closing loopA titanium-molybdenum alloy reverse-closing loop will be placed on one side of the maxillary arch, and a stainless steel reverse-closing loop will be placed on the contralateral side of the maxillary arch and activated with the same 150 g force for canine retraction. | Procedure or surgery | A stainless steel reverse closing loop, A titanium-molybdenum alloy reverse closing loop |
Primary outcome
Comparison of the rate of maxillary canine retraction using stainless steel and TMA reverse-closing loops in TAD-supported segmental mechanics over 4 months.
Time frame: 4 months
The rate of maxillary canine retraction will be compared using stainless steel and TMA reverse-closing loops in TAD-supported segmental mechanics.
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 9 Sep 2026.
- Individual participant dataSharing planned: No. Confidentiality and privacy will be preserved by utilizing unique identifying codes instead of personal identifiers
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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.
Mahmood Sajedeen, BDS,FCPS study director
Bangladesh Medical UNivbersity (BMU), Dhaka-1000
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A titanium-molybdenum alloy reverse-closing loop and A stainless steel reverse closing loop in people with Malocclusion and Canine Retraction, run by Tanzila Rafique at 1 site in Bangladesh.
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 8 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 9 Sep 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 Bangladesh. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the rate of maxillary canine retraction using stainless steel and TMA reverse-closing loops in TAD-supported segmental mechanics over 4 months. (time frame: 4 months). 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 9 Sep 2026.