NCT05361863

Brief Summary

Primary Objective Evaluating the effectiveness of canine retraction in terms of: rate of movement and rotation using 0.020-inch slot and dual-slot systems in comparison with the 0.022-inch slot system. Secondary Objectives

  • Measuring the amount of molar anchorage loss during canine retraction between the different bracket slot appliances.
  • Evaluation of alignment efficiency using different bracket slot appliances. Null Hypothesis There is insignificant difference in the effectiveness of canine retraction with different bracket slot size appliances.
  • Evaluation of the bracket slot and archwire dimensions precision

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

April 30, 2022

Last Update Submit

May 4, 2022

Conditions

Keywords

Bracket slot size, canine retarction, anchorage loss

Outcome Measures

Primary Outcomes (1)

  • The rate of movement and/or rotation

    Evaluating the effectiveness of canine retraction in terms of: rate of movement and/or rotation using 0.020-inch slot and dual-slot systems in comparison with the 0.022-inch slot system.

    10 months

Secondary Outcomes (1)

  • Molar anchorage loss assessment during canine retraction

    10 months

Study Arms (3)

0.022×0.028-inch slot (Control Group)

EXPERIMENTAL

Leveling and alignment will be performed with 0.016-inch, 0.016×0.022-inch and 0.019×0.025-inch HANT followed by a working archwire of 0.019×0.025-inch stainless steel (Hangzhou Xingchen 3B Dental Instruments and Materials Co., Hangzhou, China).

Device: Orthodontic brackets

0.020×0.028-inch slot

ACTIVE COMPARATOR

Leveling and alignment will be carried out with 0.016-inch, 0.016×0.022-inch and 0.018×0.025-inch HANT followed by a working archwire of 0.018×0.025-inch stainless steel (Hangzhou Xingchen 3B Dental Instruments and Materials Co., Hangzhou, China).

Device: Orthodontic brackets

0.018×0.028-inch slot for the anterior teeth and 0.022×0.028-inch slot for the posterior teeth

ACTIVE COMPARATOR

Leveling and alignment will be completed with 0.016-inch, 0.016×0.016-inch, and 0.016×0.022-inch HANT followed by a working archwire of 0.016×0.022-inch stainless steel (Hangzhou Xingchen 3B Dental Instruments and Materials Co., Hangzhou, China).

Device: Orthodontic brackets

Interventions

Interventions involving orthodontic brackets of different slot sizes

0.018×0.028-inch slot for the anterior teeth and 0.022×0.028-inch slot for the posterior teeth0.020×0.028-inch slot0.022×0.028-inch slot (Control Group)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 15 years and above at the start of treatment
  • Molar relationship class II or I bimaxillary proclination
  • Extraction of maxillary first premolar teeth as part of the orthodontic treatment
  • Full set of permanent teeth regardless third molars
  • No systemic diseases
  • Good oral health at the start of treatment.

You may not qualify if:

  • Orofacial clefting
  • Impacted teeth
  • Special needs patients
  • Patients undergoing orthognathic (jaw) surgery as part of their orthodontic treatment plan
  • Patients with systemic diseases requiring long-term use of Phenytoin, Cyclosporine, anti-inflammatory drugs, Bisphosphonates and systemic corticosteroids
  • Poor oral hygiene, or active periodontal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, 1001, Iraq

RECRUITING

MeSH Terms

Interventions

Orthodontic Brackets

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, FixedOrthodontic AppliancesOrthodonticsDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The appliance and archwires will be coded for each patient, so the investigator will be blinded about the size of brackets slot and archwires gauges. Moreover, data measurements and analysis will be carried out blindly too.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: The study aimed to evaluate the effectiveness of canine retraction in terms of: rate of movement and rotation using 0.020-inch slot and dual-slot systems in comparison with the 0.022-inch slot system.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2022

First Posted

May 5, 2022

Study Start

January 1, 2021

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations