NCT07014332

Brief Summary

To compare the treatment time required by elastomeric ligatures and steel ligatures, in days, to achieve complete alignment of the lower anterior teeth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

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

September 19, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
Last Updated

June 11, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 21, 2025

Last Update Submit

May 30, 2025

Conditions

Malocclusion of Anterior Teeth

Keywords

Orthodontic treatmentLigature typeSteel ligatureElastomeric ligatureAlignment time

Outcome Measures

Primary Outcomes (1)

  • Alignment time to reach little irregularity index of zero

    From recruitment to 8 months

Study Arms (1)

Group A received steel ligature and group B elastomeric ligature

OTHER
Device: Steel ligatureDevice: Elastomeric ligature

Interventions

Steel ligatureDEVICE

Steel ligatures that are used to ligate wire with bracket

Group A received steel ligature and group B elastomeric ligature
Elastomeric ligatureDEVICE

Elastomeric ligature that is used to ligate wire to bracket

Group A received steel ligature and group B elastomeric ligature

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients coming for fixed orthodontic treatment requiring premolar extraction in mandibular arch.
  • Age 12-18 years.
  • No adjunct therapeutic intervention involving functional or orthopaedic appliances.
  • Little's Irregularity index score of 7-9mm.

You may not qualify if:

  • Patients with systemic conditions and taking medications affecting tooth movement.
  • Lower anterior teeth that are missing, impacted or unerupted, or have fractured crown, restorations, Enamel Defects, Caries.
  • Poor periodontal health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber College of Dentistry

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Study Officials

  • Ahsan Mehmood Shah, Fellowship

    Khyber College of dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 21, 2025

First Posted

June 11, 2025

Study Start

September 19, 2024

Primary Completion

May 10, 2025

Study Completion

May 10, 2025

Last Updated

June 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)