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Completed

NCT Number: NCT06945575

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

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

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Key information

Conditions

Space Closure, Orthodontic

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahria University Health Sciences

Karachi, Sindh, Pakistan

About this study

T-loop and Opus loop will be placed in the right and left quadrants of the patient for canine retraction after initial leveling and alignment. canine retraction rate will be measured by using a calibrated caliper every month. canine angulation will be evaluated by periapical x-ray which will be taken before and after completion of canine retraction and anchorage loss and molar rotation will be assessed by model analysis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Opus loop

Other

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

Other names: opus

T loop

Other

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

Primary outcomes

  1. Rate of canine retraction

    Time frame: From enrollment till end of treatment at 4 months

    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.

Secondary outcomes

  1. Change in canine angulation at start of canine retraction and at the end of canine retraction

    Time frame: From enrollment till end of treatment at 4 months

    DIGORA™ Optime will be used take periapical radiographs of maxillary canine to 1st molar at the start of canine retraction and after completion of canine retraction. X-ray film holders will be used while taking periapical radiographs for standardization of X-rays. A single calibrated examiner will analyse angulation of canine by measuring an angle between vertical line drawn from buccal cusp tip of canine till root apex in reference with 2nd premolar using a protractor.

  2. Change in anchorage loss before and after completion of canine retraction

    Time frame: From enrollment till end of treatment at 4 months

    A dental cast will be made by taking an alginate impression of the patient. Anchorage loss will be measured by drawing a horizontal line from the mesiobuccal cusp tip of the right and left 1st molars. The distance between the 3rd rugae and this horizontal line will be measured on both sides using a millimetric scale, and the difference between the distance at start and after completion of canine retraction will be measured as anchorage loss.

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

    Time frame: From enrollment till end of treatment at 4 months

    dental cast will be evaluated before and after canine retraction. A diagonal line will be drawn from both left and right 1st molar distobuccal cusp tip to mesiopalatal cusp tip till mid palatal raphe. The angle formed between diagonal line and mid midpalatal raphe will be measured from both the left and right sides using a protractor. The difference between angle before and after canine retraction will be measured as a change in molar rotation

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Comparison of T-loop vs Opus Loop in Canine Retraction Efficacy and Anchorage Loss Control - a Split- Mouth, Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.