NCT02918240

Brief Summary

Fixed orthodontic braces are routinely used to straighten teeth and correct the bite of individuals. Once the braces are fit, the patient is recalled every few weeks to adjust or tighten the brace. Although convention states that the patient returns every 6-8 weeks to have the brace adjusted, there is no consensus or evidence to support a specific timeframe. Indeed some orthodontist see their patients as frequently as every 4 weeks and others as long as every 10 weeks. The aim of this investigation is to determine whether the amount of time between brace adjustment appointments has an effect on the overall treatment time. Knowing which appointment interval will lead to the shortest overall treatment time will be of benefit to patients as prolonged orthodontic treatment may be associated with an increased incidence of adverse effects associated with orthodontic treatment. Patients who are to be treated with fixed orthodontic braces at will be invited to take part in the study. Consenting subjects will be randomly allocated into one of four groups. The first will be seen to adjust their brace every 4 weeks, the second group every 6 weeks, the third group every 8 weeks and the fourth group every 10 weeks. The primary outcome measure is the total treatment time. The mean treatment time of each of the four groups will be compared to establish whether or not treatment appointment intervals affects treatment time. Secondary outcome measures will include difference in number of appointments required throughout the course of treatment between groups, differences in treatment outcomes, differences in patient compliance.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2020

Enrollment Period

5.3 years

First QC Date

September 27, 2016

Last Update Submit

September 1, 2021

Conditions

Orthodontics

Outcome Measures

Primary Outcomes (1)

  • Total Treatment Time

    Time between fitting braces and removing braces

    2 years

Secondary Outcomes (3)

  • Number of appointments needed

    2 years

  • Patient compliance survey

    2 years

  • Treatment Outcome

    2 years

Study Arms (4)

4 week interval

EXPERIMENTAL

Patients will be seen every 4 weeks to adjust their orthodontic braces

Procedure: Appointment intervalsDevice: fixed orthodontic braces

6 week interval

EXPERIMENTAL

Patients will be seen every 6 weeks to adjust their orthodontic braces

Procedure: Appointment intervalsDevice: fixed orthodontic braces

8 week interval

EXPERIMENTAL

Patients will be seen every 8 weeks to adjust their orthodontic braces

Procedure: Appointment intervalsDevice: fixed orthodontic braces

10 week interval

EXPERIMENTAL

Patients will be seen every 10 weeks to adjust their orthodontic braces

Procedure: Appointment intervalsDevice: fixed orthodontic braces

Interventions

Appointment intervalsPROCEDURE
10 week interval4 week interval6 week interval8 week interval
fixed orthodontic bracesDEVICE
10 week interval4 week interval6 week interval8 week interval

Eligibility Criteria

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

You may qualify if:

  • Children who are to be treated with upper and lower fixed orthodontic appliances
  • Aged between 10 and 18 years old at start of treatment
  • Consent to participating in trial

You may not qualify if:

  • Patients requiring functional orthodontic appliances
  • Presence of unerupted impacted teeth
  • Presence of deciduous teeth
  • Hypodontia excluding absent third molars
  • Any craniofacial anomalies
  • Medical contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grosvenor House Orthodontic Practice

Royal Tunbridge Wells, Kent, TN1 2DU, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2021

Study Completion

August 1, 2022

Last Updated

September 2, 2021

Record last verified: 2020-09

Locations

GB(1)