OrthodonticsNCT02918240
How Often Should We See Our Orthodontic Patients
A study testing Appointment intervals and fixed orthodontic braces in people with Orthodontics, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontics
- What is being tested?
- Appointment intervals and fixed orthodontic braces
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients requiring functional orthodontic appliances
- Presence of unerupted impacted teeth
- Presence of deciduous teeth
- Hypodontia excluding absent third molars
- Any craniofacial anomalies
- Medical contraindications
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Grosvenor House Orthodontic Practice
Royal Tunbridge Wells, Kent, TN1 2DU
About this study
Official title: The Effect of Different Appointment Intervals on Treatment Time in Patients Receiving Orthodontic Treatment With Fixed Appliances
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.
Read more
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.
Read the 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.
- Conditions
- Orthodontics
- Being tested
- Appointment intervals, fixed orthodontic braces
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appointment intervalsProcedure or surgery
fixed orthodontic bracesDevice
| Study group | Role | What they receive |
|---|---|---|
| 4 week interval | Experimental | Patients will be seen every 4 weeks to adjust their orthodontic braces Receives: Procedure: Appointment intervals; Device: fixed orthodontic braces |
| 6 week interval | Experimental | Patients will be seen every 6 weeks to adjust their orthodontic braces Receives: Procedure: Appointment intervals; Device: fixed orthodontic braces |
| 8 week interval | Experimental | Patients will be seen every 8 weeks to adjust their orthodontic braces Receives: Procedure: Appointment intervals; Device: fixed orthodontic braces |
| 10 week interval | Experimental | Patients will be seen every 10 weeks to adjust their orthodontic braces Receives: Procedure: Appointment intervals; Device: fixed orthodontic braces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Treatment Time
Time between fitting braces and removing braces
Measured: 2 years
Secondary outcomes (3)
Number of appointments needed
Total clinical time used
Measured: 2 years
Patient compliance survey
This will be measured by comparing oral hygiene, failed/cancelled appointment and broken braces between groups
Measured: 2 years
Treatment Outcome
PAR scores will be used to compare outcome between groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918240
- Sponsor's protocol ID
- 16/LO/0522
- Status last verified
- Sep 2020
- First submitted
- 27 Sep 2016
- Last updated
- 2 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Appointment Intervals on Treatment Time in Patients Receiving Orthodontic Treatment With Fixed Appliances
- ClinicalTrials.gov ID
- NCT02918240
- Acronym / sponsor ID
- 16/LO/0522
- Conditions
- Orthodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4 week interval | Experimental | Procedure: Appointment intervals, Device: fixed orthodontic bracesPatients will be seen every 4 weeks to adjust their orthodontic braces |
| 6 week interval | Experimental | Procedure: Appointment intervals, Device: fixed orthodontic bracesPatients will be seen every 6 weeks to adjust their orthodontic braces |
| 8 week interval | Experimental | Procedure: Appointment intervals, Device: fixed orthodontic bracesPatients will be seen every 8 weeks to adjust their orthodontic braces |
| 10 week interval | Experimental | Procedure: Appointment intervals, Device: fixed orthodontic bracesPatients will be seen every 10 weeks to adjust their orthodontic braces |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Patients requiring functional orthodontic appliances
- Presence of unerupted impacted teeth
- Presence of deciduous teeth
- Hypodontia excluding absent third molars
- Any craniofacial anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Appointment intervals | Procedure or surgery | 10 week interval, 4 week interval, 6 week interval, 8 week interval |
| fixed orthodontic braces | Device | 10 week interval, 4 week interval, 6 week interval, 8 week interval |
Primary outcome
Total Treatment Time
Time frame: 2 years
Time between fitting braces and removing braces
3 secondary outcomes
Number of appointments needed
Time frame: 2 years
Patient compliance survey
Time frame: 2 years
Treatment Outcome
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appointment intervals and fixed orthodontic braces in people with Orthodontics, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Treatment Time (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.