Comparison of T-loop vs Opus Loop in Canine Retraction Efficacy and Anchorage Loss Control

NCT06945575 | Completed DMC

• 1 other identifier: DowUHS 2
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this split-mouth randomized control trial is to compare the rate of canine retraction between the T loop and the Opus loop. The secondary objectives are to compare the angulation of the canine, changes in the first molar position in terms of anchorage loss, and molar rotation for the two loops used T-loop and Opus loop will be placed randomly on the right and left quadrants of patients for canine retraction and outcomes will be measured before and after completion of canine retraction

Conditions

Space Closure, Orthodontic

Outcome Measures

Primary Outcomes (1)

• Rate of canine retraction

  The rate of canine retraction will be calculated by "the amount of canine retraction (in millimeters) divided by the time interval". The amount of canine retraction will be assessed by measuring the distance from the canine cusp tip to the mesio-buccal (MB) cusp tip of the 1st molar with a calibrated caliper at the time of placement of loops and at every month by a single calibrated clinician. The duration will be measured as a time interval and each time interval will be 4 weeks.

  From enrollment till end of treatment at 4 months

Secondary Outcomes (3)

• Change in canine angulation at start of canine retraction and at the end of canine retraction

  From enrollment till end of treatment at 4 months

• Change in anchorage loss before and after completion of canine retraction

  From enrollment till end of treatment at 4 months

• Change in molar rotation at before and after completion of canine reatraction

  From enrollment till end of treatment at 4 months

Study Arms (2)

Opus loop

ACTIVE COMPARATOR

Opus loop will be inserted from 1st molar to canine for canine retraction. it will be activated every month

Other: Opus loop

T-loop

ACTIVE COMPARATOR

T loop will be inserted from 1st molar to canine for canine retraction. it will be activated every month

Other: T loop

Interventions

Opus loop OTHER

17X25SS will used to fabricate opus loop which is L shaped loop with helix

Also known as: opus

Opus loop

T loop OTHER

17X25SS wire will be used to fabricate T-loop which is a T shaped loop

T-loop

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 14 -40 years Extractions of maxillary 1st premolars Class 1, 1/4th, 1/2, and 3/4th unit Class II molar relation Presence of all teeth up to the second molar Good oral hygiene

You may not qualify if:

• Full cusp Class II Developmental, medical, or genetic problems Patient using bisphosphonates Spacing in dentition Grossly carious upper molars that cannot be restored Patient with active periodontal disease Severe crowding

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Bahria University Health Sciences

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

Opus PCF

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 25, 2025
• Study Start: February 4, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-04

Locations

PA (1)