Space Closure, OrthodonticNCT06945575
Comparison of T-loop vs Opus Loop in Canine Retraction Efficacy and Anchorage Loss Control
A study testing Opus loop and T loop in people with Space Closure, Orthodontic, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Space Closure, Orthodontic
- What is being tested?
- Opus loop and T loop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Feb 2025to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of T-loop vs Opus Loop in Canine Retraction Efficacy and Anchorage Loss Control - a Split- Mouth, Randomized Clinical Trial
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
Read the detailed description
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
- Conditions
- Space Closure, Orthodontic
- Being tested
- Opus loop, T loop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opus loopOther
Also called opus
17X25SS will used to fabricate opus loop which is L shaped loop with helix
T loopOther
17X25SS wire will be used to fabricate T-loop which is a T shaped loop
| Study group | Role | What they receive |
|---|---|---|
| Opus loop | Active comparator | Opus loop will be inserted from 1st molar to canine for canine retraction. it will be activated every month Receives: 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 Receives: Other: T loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From enrollment till end of treatment at 4 months
Change in anchorage loss before and after completion of canine retraction
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.
Measured: From enrollment till end of treatment at 4 months
Change in molar rotation at before and after completion of canine reatraction
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
Measured: From enrollment till end of treatment at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start4 Feb 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Space Closure, OrthodonticStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Moin, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945575
- Sponsor's protocol ID
- DowUHS 2
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of T-loop vs Opus Loop in Canine Retraction Efficacy and Anchorage Loss Control - a Split- Mouth, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06945575
- Acronym / sponsor ID
- DowUHS 2
- Conditions
- Space Closure, Orthodontic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 25 Apr 2025 (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 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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opus loop | Active comparator | Other: Opus loopOpus loop will be inserted from 1st molar to canine for canine retraction. it will be activated every month |
| T-loop | Active comparator | Other: T loopT loop will be inserted from 1st molar to canine for canine retraction. it will be activated every month |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Opus loopAlso: opus17X25SS will used to fabricate opus loop which is L shaped loop with helix | Other | Opus loop |
| T loop17X25SS wire will be used to fabricate T-loop which is a T shaped loop | Other | T-loop |
Primary outcome
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.
3 secondary outcomes
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
Change in anchorage loss before and after completion of canine retraction
Time frame: From enrollment till end of treatment at 4 months
Change in molar rotation at before and after completion of canine reatraction
Time frame: From enrollment till end of treatment at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Space Closure, Orthodontic
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Comparison of Maxillary Canine Retraction Rate With and Without Power Arm
Orthodontic Anchorage, Power Arm Sliding
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Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
Malocclusion Class II, Malocclusion, Angle Class I
Recruiting
Gingival Cleft Development at Two Time Points of Canine Retraction
Gingival Cleft, Orthodontic Space Closure
Recruiting
Effect of Force Magnitude on Canine Retraction and Gingival Crevicular Fluid Proteome
Tooth Crowding
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opus loop and T loop in people with Space Closure, Orthodontic, run by Dow University of Health Sciences at 1 site in Pakistan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jul 2025. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of canine retraction (time frame: From enrollment till end of treatment at 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 4 Jul 2025.