How Often Should We See Our Orthodontic Patients

Orthodontics Clinical Trial

Official title:

The Effect of Different Appointment Intervals on Treatment Time in Patients Receiving Orthodontic Treatment With Fixed Appliances

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02918240
• Other study ID #: 16/LO/0522
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 2022

Study information

• Verified date: September 2020
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontics

Intervention

Procedure:
• Appointment intervals

Device:
• fixed orthodontic braces

Locations

Country	Name	City	State
United Kingdom	Grosvenor House Orthodontic Practice	Tunbridge Wells	Kent

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Treatment Time	Time between fitting braces and removing braces	2 years
Secondary	Number of appointments needed	Total clinical time used	2 years
Secondary	Patient compliance survey	This will be measured by comparing oral hygiene, failed/cancelled appointment and broken braces between groups	2 years
Secondary	Treatment Outcome	PAR scores will be used to compare outcome between groups	2 years