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How Often Should We See Our Orthodontic Patients

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ClinicalTrials.gov Identifier: NCT02918240
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
King's College London

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.


Condition or disease Intervention/treatment Phase
Orthodontics Procedure: Appointment intervals Device: fixed orthodontic braces Not Applicable

Detailed Description:

Patients at Grosvenor House Orthodontic Practice who are to be treated with fixed orthodontic appliances and fulfil the inclusion criteria will be invited to participate in the research.

Once consented, patients will be randomly allocated to one of four groups, each group specifying a different amount of time between appointments following brace fitting.

Once the subject has had their fixed orthodontic appliance fit, they will be offered appointments every 4 weeks, 6 weeks, 8 weeks or 10 weeks to adjust there brace, depending on which group they are in.

All patients will have both arches bonded simultaneously in a standardized way using 3M Unitek pre-coated Gemini brackets with MBT prescription. The initial archwire will be 0.014 nickel titanium ligated using standard elastomeric ligation. Patients will then progress to 0.018 nickel titanium followed by 0.019x0.025 heat activated nickel titanium followed by 0.019x0.025 stainless steel. Round stainless steel archwires will be permitted if indicated for finishing or as a lower working archwire in Class III patients but the original archwire sequence will be adhered to wherever possible. Progression to the next archwire will only occur once each archwire becomes passive.

Space closure of extraction spaces where indicated will be done with E-Links (TP Orthodontics, Inc.) running from the hook on the molar tube to a hook crimped onto the archwire between the lateral incisor and canine.

Patients who fail to attend or cancel appointments will be offered another appointment within 1 week of the original appointment.

Once the orthodontic treatment is complete to the satisfaction of the patient and orthodontist, the brace will be removed. The time in days from brace fit to brace removal will be noted and a total treatment time will be recorded for each subject. A comparison will be made on the total treatment time between the four groups.

A basic oral hygiene examination will be done at each appointment. The data will be analysed following treatment to determine whether appointment frequency has an impact on oral hygiene.

A record will also be made of the number of appointments missed or cancelled and a comparison between groups will be made during the analysis.

Treatment outcomes will be determined using the PAR (peer assessment rating) system which assesses certain features of the occlusion from pre treatment and post treatment plaster models, quantifying the level of improvement brought about by treatment. The outcome of treatment, as measured by PAR, will be compared between groups.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Different Appointment Intervals on Treatment Time in Patients Receiving Orthodontic Treatment With Fixed Appliances
Actual Study Start Date : September 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
Experimental: 4 week interval
Patients will be seen every 4 weeks to adjust their orthodontic braces
Procedure: Appointment intervals
Device: fixed orthodontic braces
Experimental: 6 week interval
Patients will be seen every 6 weeks to adjust their orthodontic braces
Procedure: Appointment intervals
Device: fixed orthodontic braces
Experimental: 8 week interval
Patients will be seen every 8 weeks to adjust their orthodontic braces
Procedure: Appointment intervals
Device: fixed orthodontic braces
Experimental: 10 week interval
Patients will be seen every 10 weeks to adjust their orthodontic braces
Procedure: Appointment intervals
Device: fixed orthodontic braces



Primary Outcome Measures :
  1. Total Treatment Time [ Time Frame: 2 years ]
    Time between fitting braces and removing braces


Secondary Outcome Measures :
  1. Number of appointments needed [ Time Frame: 2 years ]
    Total clinical time used

  2. Patient compliance survey [ Time Frame: 2 years ]
    This will be measured by comparing oral hygiene, failed/cancelled appointment and broken braces between groups

  3. Treatment Outcome [ Time Frame: 2 years ]
    PAR scores will be used to compare outcome between groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918240


Locations
Layout table for location information
United Kingdom
Grosvenor House Orthodontic Practice
Tunbridge Wells, Kent, United Kingdom, TN1 2DU
Sponsors and Collaborators
King's College London
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02918240    
Other Study ID Numbers: 16/LO/0522
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: September 2016