NCT06567730

Brief Summary

The objective of this study is to compare the canine retraction rate (in mm with a 100 mm marked scale) using Ni-Ti closed-coil springs versus elastomeric power chains during canine retraction in subjects with first premolar extractions over a period of three months. After the extraction of all first premolars under local anesthesia. For canine retraction, Ni-Ti closed-coil springs and elastomeric power chains will be randomly allocated to the right and left quadrants of both arches. Radiographic measurement (root resorption) and clinical measurements (canine retraction, plaque accumulation and gingival health) will be recorded at four points in time. First, at the start of the canine retraction (T0), after first month (T1), second month (T2) and third month follow-up (T3).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 16, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

August 16, 2024

Last Update Submit

January 28, 2025

Conditions

Keywords

canine retraction rate

Outcome Measures

Primary Outcomes (1)

  • Canine retraction rate

    The retraction rate of canine will be the distance travelled divided by the time interval needed for closure of spaces. It will be noted at four-time intervals i.e at the start of the canine retraction (T0), after first month (T1), second month (T2) and third month follow-up (T3).

    3 months

Secondary Outcomes (3)

  • Root resorption

    3 months

  • Gingival health

    3 months

  • Plaque index

    3 months

Study Arms (2)

Ni-ti closed Coil spring

EXPERIMENTAL

For canine retraction, Ni-Ti closed-coil springs will be randomly allocated to the right and left quadrants of both arches

Other: Ni-ti Closed-coil Spring

Elastomeric power chain

ACTIVE COMPARATOR

For canine retraction, elastomeric power chains will be randomly allocated to the right and left quadrants of both arches

Other: Elastomeric Power chain

Interventions

Ni-Ti closed-coil spring is a passive compressed spring made up of super elastic Nickel-titanium. Two eyelets are attached to each side of the coil to facilitate its application. The eyelets will be engaged in the hooks of the second premolar and canine brackets and will apply a force of 150 gm.

Also known as: closing coil, closing coil spring
Ni-ti closed Coil spring

Elastomeric power chains are resilient and latex-free orthodontic materials. They are made up of elastic material and consist of many connected rings. Each ring is engaged in a bracket to apply a force of 175-300 gm.

Also known as: Power chain
Elastomeric power chain

Eligibility Criteria

Age13 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged between 13 - 40 years
  • Patients undergoing fixed orthodontic treatment
  • Patients requiring all first premolars extraction as part of orthodontic treatment
  • Patients with all permanent teeth present and erupted (except for second and third molars)
  • All patients who will sign the informed consent/assent form

You may not qualify if:

  • Patients with systemic diseases that can affect tooth movements
  • Patients with uncontrolled periodontal disease
  • Patients with craniofacial syndromes
  • Pregnant or lactating mothers
  • Patients with bracket failures greater than three times per bracket during the study
  • Patients on medications that can affect tooth movements
  • Patients with Nickel allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Wazwaz F, Seehra J, Carpenter GH, Papageorgiou SN, Cobourne MT. Duration of canine retraction with fixed appliances: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2023 Feb;163(2):154-172. doi: 10.1016/j.ajodo.2022.08.009. Epub 2022 Dec 1.

    PMID: 36464569BACKGROUND
  • Kulshrestha RS, Tandon R, Chandra P. Canine retraction: A systematic review of different methods used. J Orthod Sci. 2015 Jan-Mar;4(1):1-8. doi: 10.4103/2278-0203.149608.

    PMID: 25657985BACKGROUND
  • Makhlouf M, Aboul-Ezz A, Fayed MS, Hafez H. Evaluating the Amount of Tooth Movement and Root Resorption during Canine Retraction with Friction versus Frictionless Mechanics Using Cone Beam Computed Tomography. Open Access Maced J Med Sci. 2018 Feb 5;6(2):384-388. doi: 10.3889/oamjms.2018.066. eCollection 2018 Feb 15.

    PMID: 29531610BACKGROUND

MeSH Terms

Conditions

Root ResorptionGingivitis

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Mubassar Fida, BDS,FCPS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Munnal Gulzar, BDS

CONTACT

Mubassar Fida, BDS,FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 23, 2024

Study Start

March 1, 2025

Primary Completion

September 1, 2025

Study Completion

November 1, 2025

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share