NCT07141836

Brief Summary

This clinical study aimed to evaluate the effectiveness of Elastics and Elastic chains in maxillary canine retraction. Participants of this study were patients undergoing maxillary canine retraction after first premolar extraction. The study aimed to determine an effective method for better controlling tooth movement. This study was initiated on 01-2024. Initially, I was not aware of the importance of early registration on ClinicalTrials.gov. Registration was completed after the study began to ensure transparency and adherence to ethical guidelines. All study procedures and protocols have been conducted under the supervision of the academic advisor. All study procedures and protocols have been followed according to institutional and ethical guidelines

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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

January 30, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

August 15, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

ElasticsElastomeric chainsRandomized clinical trialSplit mouthDigital modelsCanine retraction

Outcome Measures

Primary Outcomes (3)

  • Rate of maxillary canine retraction by elastics and elastic chains on each side

    The canine retraction rate was measured on superimposed digital casts of pre and post retraction models.

    Difference between pe and post retraction canine position during 15 weeks

  • Measurement of the Tipping movement occurred by each method

    Tipping angle on each side was measured on Orthopantomograms (OPG).

    Pre and post retraction during 15 weeks

  • Measurements of rotation resulted by elastic and elastic chain

    The rotational angle was measured on each side by the digital models

    Pre and post-retraction during 25 weeks

Study Arms (2)

Elastic chains

EXPERIMENTAL

This side received maxillary canine retraction using elastic chains

Procedure: Elastomeric chain

Elastics

EXPERIMENTAL

This side received maxillary canine retraction with Elastics on the contralateral side of the arch

Procedure: Elastics

Interventions

Elastic chain used to apply force that is capable of canine retraction. The chains were attached between canine bracket and molar band on the side that selected Randomly.

Also known as: Elastic chains, Power chain
Elastic chains
ElasticsPROCEDURE

Elastics were used to bring a continuous force for maxillary canine retraction in orthodontic patients. Elastics were stretched between the canine bracket and the molar band to retract the canine distally

Also known as: Elastic band, Intramaxillary elastic
Elastics

Eligibility Criteria

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

You may qualify if:

  • Patients' treatment required 1st premolar extractions in the maxillary arch and space closure involving canine retraction.
  • Teeth in the buccal segments were without any gross anatomic root anomalies as determined by panoramic radiographs.
  • There is no gross evidence of asymmetric bone loss in the buccal segments of a given arch as determined by panoramic radiographs.
  • Crown/root ratios of contralateral canines and premolars are within 3 mm of one another as determined by panoramic radiographs.

You may not qualify if:

  • Patients with gross anatomical anomalies in upper maxillary canines
  • Patients with growth and development problems.
  • Evidence of bone loss.
  • Presence of Impacted Canine.
  • History of long-term use of NSAIDs and corticosteroids or drugs affect bone metabolism. Patients who reported any medication interfering with bone metabolism or patients with severe skeletal discrepancies indicated for orthognathic treatment.
  • Patients with latex materials allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deparyment of Orthodontics - Faculty of Dentistry- Sana'a University

Sanaa, 967, Yemen

Location

Related Publications (1)

  • Jagtap SB, Bhosale VI, Patil AS. Comparative evaluation of interrupted and intermittent forces on canine retraction: an in vivo study. Folia Med (Plovdiv). 2021 Oct 31;63(5):686-691. doi: 10.3897/folmed.63.e54247.

Related Links

MeSH Terms

Interventions

Elasticity

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Asraa H Taha, MSc Student

    Faculty of Dentistry - Sana'a University

    PRINCIPAL INVESTIGATOR
  • Reema A Al-Eriani, PhD of Pedodontics

    Faculty of Dentistry- Sana'a University

    STUDY DIRECTOR
  • Ghamdan A Al-Harazi, PhD of Orthodontics

    Faculty of Dentistry- Sana'a University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the clinical intervention, neither the patients nor the investigator could be blinded to the treatment. However, researcher blinding was implemented at the data measurement stage through coding of OPG images and dental models by inter examiner, before measurements began. The researcher was blinded to patient identities and the type of retraction method used on each side (elastic chain vs. elastics).
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study was designed as a split-mouth randomized clinical trial, where each participant received both interventions. One side of the maxillary arch was retracted with elastic chains, while the contralateral side received elastics. This design allows for direct intra-individual comparison between the two force delivery systems.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in orthodontics

Study Record Dates

First Submitted

August 15, 2025

First Posted

August 26, 2025

Study Start

January 30, 2024

Primary Completion

April 11, 2025

Study Completion

May 1, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

I plan to share de-identified individual participant data (IPD) related to the main outcomes of this study. The data will be available upon reasonable request and after the results are published. Only researchers with valid proposals will be allowed access. Data will be shared through secure methods and only for academic purposes

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Start Date: 01-Jan-2026 End Date: 31-Dec-2030
Access Criteria
Qualified researchers who submit a valid research proposal will be able to access de-identified individual participant data, including digital models and treatment outcome measurements. Data will be available through a secure online repository upon approval of the research proposal.

Locations