NCT05882526

Brief Summary

evaluate and compare the efficiency between elastomeric chains and burston T-loop retractors in terms of rate of maxillary canine retraction and canine movements

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

May 21, 2023

Last Update Submit

May 21, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • rate of canine retraction

    distance which canine move pre and post retraction

    FOUR months

  • Canine rotation

    angulation of canine

    4 MONTH

  • canine tipping

    canine movement in mesial and dISTAL

    4 month

Study Arms (2)

Evaluation of elastomeric power chain for orthodontic maxillary canine retraction

ACTIVE COMPARATOR

20 Orthodontic patient treated by for elastomeric power chain canine retraction split mouth.

Device: BURSTONE T-LOOP

Evaluation of T loop for orthodontic maxillary canine retraction

ACTIVE COMPARATOR

20 Orthodontic patient treated by T loop for canine retraction split mouth

Device: BURSTONE T-LOOP

Interventions

Split mouth study one side using elastomeric power chain and other side using T loops

Also known as: elastomeric power chain
Evaluation of T loop for orthodontic maxillary canine retractionEvaluation of elastomeric power chain for orthodontic maxillary canine retraction

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Class I or bimaxillary protursion , orthodontic patients, with moderate to severe crowding who are indicated for maxillary first premolar extraction. 2- All permanent teeth are erupted (3rd molars are not included). 3- Good oral and general health. 4- No previous orthodontic treatment.

You may not qualify if:

  • \- Orthodontic cases that could be treated with no indication for extraction therapy.
  • Orthodontic cases that are indicate for the extraction of any tooth other than maxillary first premolars. 3- Patients with systemic diseases that might interfere with the of orthodontic tooth movement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 050, Egypt

Location

Related Publications (2)

  • Barsoum HA, ElSayed HS, El Sharaby FA, Palomo JM, Mostafa YA. Comprehensive comparison of canine retraction using NiTi closed coil springs vs elastomeric chains. Angle Orthod. 2021 Jul 1;91(4):441-448. doi: 10.2319/110620-916.1.

  • Davis S, Sundareswaran S, James J. Comparative evaluation of the efficiency of canine retraction using modified Marcotte and T-loop retraction springs - A split-mouth, randomized clinical trial. J Orthod Sci. 2019 May 23;8:9. doi: 10.4103/jos.JOS_101_18. eCollection 2019.

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • AHMED MAHER FOUDA

    Mansoura University

    STUDY CHAIR
  • nehal fouad elbelasy

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Evaluation of T loop for orthodontic maxillary canine retraction Evaluation of POWER CHAIN for orthodontic maxillary canine retraction
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
investigator

Study Record Dates

First Submitted

May 21, 2023

First Posted

May 31, 2023

Study Start

May 15, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations