NCT04020952

Brief Summary

trial will be done to evaluate the effect of archwire gauge on the rate of canine retraction, canine tip and torque, root resorption and loss of anchorage in maxillary dental protrusion cases requiring first premolars extraction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration 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

First Submitted

Initial submission to the registry

July 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

July 9, 2019

Last Update Submit

July 20, 2022

Conditions

Keywords

canine retractionarchwire gauge

Outcome Measures

Primary Outcomes (1)

  • rate of canine retraction

    the distance that canine moved every month

    6 months

Secondary Outcomes (4)

  • change in canine tip

    6 months

  • change in canine torque

    6 months

  • loss of molar anchorage

    6 months

  • amount of canine root resorption

    6 months

Study Arms (3)

st.st 0.019×0.025" wire

ACTIVE COMPARATOR
Other: st.st 0.019×0.025" wire

st.st 0.016×0.022" wire

EXPERIMENTAL
Other: st.st 0.016×0.022" wire

st.st 0.017×0.025" wire

EXPERIMENTAL
Other: st.st 0.017×0.025" wire

Interventions

rectangular stainless steel wire that will be used during canine retraction after first premolars extraction

st.st 0.019×0.025" wire

rectangular stainless steel wire that will be used during canine retraction after first premolars extraction

st.st 0.016×0.022" wire

rectangular stainless steel wire that will be used during canine retraction after first premolars extraction

st.st 0.017×0.025" wire

Eligibility Criteria

Age16 Years - 26 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsadult female patients
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adult females (age range 18-28 years old).
  • Maxillary dental protrusion indicating first premolars extraction.
  • Full permanent dentition (not necessitating third molars).

You may not qualify if:

  • Patients having systemic diseases or on medications that would affect tooth movement.
  • Active periodontal disease or obvious bone resorption in maxillary arch.
  • Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting … etc.).
  • Previous orthodontic treatment.
  • Missing teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Abdelkader ASM, Abd El-Ghafour M, Dehis HM, El Sharaby FA, Labib AH. Effect of archwire size on the rate of canine retraction in adult women : A randomized clinical trial. J Orofac Orthop. 2025 Mar 25. doi: 10.1007/s00056-025-00577-y. Online ahead of print.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor is not informed about the gauge of the wire used for patients
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups of patients each receives different wire gauge during canine retraction phase during space closure.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
masters degree student

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 16, 2019

Study Start

September 10, 2019

Primary Completion

September 20, 2020

Study Completion

July 15, 2021

Last Updated

July 22, 2022

Record last verified: 2022-07

Locations