NCT02080338

Brief Summary

The purpose of this study is to compare the 0.018-inch and 0.022-inch bracket slot systems to determine which is more effective for orthodontic treatment .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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 1, 2010

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

7.2 years

First QC Date

March 2, 2014

Last Update Submit

June 26, 2018

Conditions

Malocclusion

Keywords

Orthodontic, Bracket slot, Effective, Randomized, Duration

Outcome Measures

Primary Outcomes (1)

  • Duration of fixed appliance orthodontic treatment

    Number of months in orthodontic treatment from the start of fitting the fixed orthodontic appliance until the removal of the fixed appliance.

    Completion of orthodontic treatment, an expected average of 24 months.

Secondary Outcomes (1)

  • Occlusal treatment outcome

    The ooclusal outcome will be assessed at the end of orthodontic treatment, an average of 24 months.

Other Outcomes (3)

  • Biological side effect of fixed appliance orthodontic treatment

    At 9 months from the start of treatment

  • Patient perception of wearing the fixed appliance

    At six months from start of treatment

  • Patient perception of the of fixed appliance treatment outcome

    Following the end of orthodontic treatment , an average of 24 months.

Study Arms (2)

0.018 bracket slot system

EXPERIMENTAL

Participants treated using 0.018-inch orthodontic bracket slot system

Device: Orthodontic bracket slot system

0.022 bracket slot system

ACTIVE COMPARATOR

Participants treated using 0.022-inch orthodontic bracket slot system

Device: Orthodontic bracket slot system

Interventions

Orthodontic bracket slot systemDEVICE

Orthodontic treatment using different orthodontic bracket slot systems

0.018 bracket slot system0.022 bracket slot system

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo dual arch fixed appliance orthodontic treatment in any of the three trial centers will be invited to participate in this trial by the operator planning to conduct their orthodontic treatment.

You may not qualify if:

  • Patients who have undergone previous orthodontic treatment including fixed, removable and functional appliances.
  • Patients less than 12 years old at the start of orthodontic treatment.
  • Patients with orofacial clefting, severe hypodontia, and special needs patients.
  • Patients undergoing orthognathic (jaw) surgery as part of their orthodontic treatment plan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Springfield Medical Center

Arbroath, DD11 1ES, United Kingdom

Location

Dundee Dental Hospital

Dundee, DD1 4HN, United Kingdom

Location

Perth Royal Infirmary

Perth, PH1 1NX, United Kingdom

Location

Related Publications (4)

  • Yassir YA, El-Angbawi AM, McIntyre GT, Revie GF, Bearn DR. A randomized clinical trial of the effectiveness of 0.018-inch and 0.022-inch slot orthodontic bracket systems: part 2-quality of treatment. Eur J Orthod. 2019 Mar 29;41(2):143-153. doi: 10.1093/ejo/cjy038.

    PMID: 30007333DERIVED

  • El-Angbawi AM, Yassir YA, McIntyre GT, Revie GF, Bearn DR. A randomized clinical trial of the effectiveness of 0.018-inch and 0.022-inch slot orthodontic bracket systems: part 3-biological side-effects of treatment. Eur J Orthod. 2019 Mar 29;41(2):154-164. doi: 10.1093/ejo/cjy039.

    PMID: 30007330DERIVED

  • Yassir YA, El-Angbawi AM, McIntyre GT, Revie GF, Bearn DR. A randomized clinical trial of the effectiveness of 0.018-inch and 0.022-inch slot orthodontic bracket systems: part 1-duration of treatment. Eur J Orthod. 2019 Mar 29;41(2):133-142. doi: 10.1093/ejo/cjy037.

    PMID: 30007300DERIVED

  • El-Angbawi AM, Bearn DR, McIntyre GT. Comparing the effectiveness of the 0.018-inch versus the 0.022-inch bracket slot system in orthodontic treatment: study protocol for a randomized controlled trial. Trials. 2014 Oct 6;15:389. doi: 10.1186/1745-6215-15-389.

    PMID: 25288125DERIVED

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Ahmed M El-Angbawi, PhD

    University of Dundee

    PRINCIPAL INVESTIGATOR

  • David R Bearn, Prof

    University of Dundee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Orthodontics

Study Record Dates

First Submitted

March 2, 2014

First Posted

March 6, 2014

Study Start

January 1, 2010

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

GB(3)