An interventional study of A titanium-molybdenum alloy reverse-closing loop and A stainless steel reverse closing loop in Malocclusion, Canine Retraction and Orthodontics, sponsored by Tanzila Rafique. Enrolling by invitation at 1 site in Bangladesh. Open to participants aged 15 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Tanzila Rafique · Not applicable, Interventional, and Treatment
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:
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.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 16 is below the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Tanzila Rafique is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
Procedure: A titanium-molybdenum alloy reverse-closing loop · Procedure: A stainless steel reverse closing loop
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.
Procedure: A titanium-molybdenum alloy reverse-closing loop · Procedure: A stainless steel reverse closing loop
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 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.
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.
Time frame: 4 months
Plan to share: No — Confidentiality and privacy will be preserved by utilizing unique identifying codes instead of personal identifiers
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Aug 2026, 13 months.
Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 13 months is below that.
Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.
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Tanzila Rafique