NCT07645417

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jul 2025Dec 2026

Study Start

First participant enrolled

July 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Stainless steel wire, TMA wire, reverse closing loop, TAD, maxillary canine retraction, segmental mechanics, orthodontic anchorage, canine angulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 months

Study Arms (2)

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.

Procedure: A titanium-molybdenum alloy reverse-closing loopProcedure: 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.

Procedure: A titanium-molybdenum alloy reverse-closing loopProcedure: A stainless steel reverse closing loop

Interventions

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.

A stainless steel reverse closing loopA titanium-molybdenum alloy 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 stainless steel reverse closing loopA titanium-molybdenum alloy reverse closing loop

Eligibility Criteria

Age15 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh Medical University (BMU), Dhaka,1000

Dhaka, 1000, Bangladesh

Location

Study Officials

  • Mahmood Sajedeen, BDS,FCPS

    Bangladesh Medical UNivbersity (BMU), Dhaka-1000

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split-mouth randomized clinical study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Rafique

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 12, 2026

Study Start

July 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Confidentiality and privacy will be preserved by utilizing unique identifying codes instead of personal identifiers

Locations