UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056851 |
|---|---|
| Receipt number | R000064978 |
| Scientific Title | comparison of t loop vs opus loop in canine retraction efficacy and anchorage loss control a split mouth randomized clinical trial |
| Date of disclosure of the study information | 2025/01/29 |
| Last modified on | 2025/01/29 12:45:25 |
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Basic information
Public title
comparison of t loop vs opus loop in canine retraction efficacy and anchorage loss control a split mouth randomized clinical trial
Acronym
comparison of t loop vs opus loop in canine retraction efficacy and anchorage loss control a split mouth randomized clinical trial
Scientific Title
comparison of t loop vs opus loop in canine retraction efficacy and anchorage loss control a split mouth randomized clinical trial
Scientific Title:Acronym
comparison of t loop vs opus loop in canine retraction efficacy and anchorage loss control a split mouth randomized clinical trial
Region
| Asia(except Japan) |
Condition
Condition
Space closure during orthodontic treatment using T-loop and opus loop
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the rate of canine retraction, change in canine angulation, anchorage loss and molar rotation between T loop and Opus loop
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of canine retraction
Key secondary outcomes
change in canine angulation
anchorage loss
molar rotation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Opus loop in one quadrant placed for canine retraction and activated till completion of canine retraction
Interventions/Control_2
T- loop in one quadrant placed for canine retraction and activated till completion of canine retraction
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 14 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) age 14 -40 years
2) a treatment plan involving bilateral extractions of maxillary first premolars
3) Class 1, 1/4th, 1/2 and 3/4th unit Class II molar relation
4) presence of all teeth up to second molar
5) good oral hygiene
Key exclusion criteria
1) full cusp Class II
2) developmental, medical or genetic problems
3) patient using bisphosphonates
4) spacing in dentition
5) grossly carious upper molars which cannot be restored
6) patient with active periodontal disease 7) severe crowding.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Ayesha |
| Middle name | Ashraf |
| Last name | Khan |
Organization
Bahria University Health Sciences
Division name
Department of Orthodontics
Zip code
75530
Address
Bahria University Health Sciences ,Sailor street, adjacent PNS shifa DHA Phase 2, Karachi, Pakistan
TEL
+923472069658
ayeshaashrafkhan@gmail.com
Public contact
Name of contact person
| 1st name | Ayesha |
| Middle name | Ashraf |
| Last name | Khan |
Organization
Bahria University Health Sciences
Division name
Department of Orthdontics
Zip code
75530
Address
Bahria University Health Sciences ,Sailor street, adjacent PNS shifa DHA Phase 2, Karachi, Pakistan
TEL
+923472069658
Homepage URL
ayeshaashrafkhan@gmail.com
Sponsor or person
Institute
Bahria University Health Sciences
Institute
Department
Personal name
Funding Source
Organization
NONE
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bahria University Health Sciences
Address
Bahria University Health Sciences ,Sailor street, adjacent PNS shifa DHA Phase 2, Karachi, Pakistan
Tel
+92-21-35319491-9
irbbuhsinfo@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 29 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064978
