Appointment Intervals and Orthodontic Tooth Movement

February 4, 2020 updated by: Guy's and St Thomas' NHS Foundation Trust

A Randomized Clinical Trial Investigating the Effect of Appointment Intervals on Orthodontic Tooth Alignment

The purpose of this study is to investigate rapidity of tooth alignment in a randomised clinical trial of orthodontic patients allocated randomly into two different appointment intervals groups. First group will be reviewed every two weeks to adjust their braces while the second group will be reviewed every 8 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Orthodontics is a branch of dentistry concerned primarily with the correction of dental crowding or tooth malalignment. The first phase of fixed appliance orthodontic treatment is concerned with tooth alignment and relies upon a rapid and predictable response of the appliance system to the forces applied by the aligning archwire. The appropriate length of time between orthodontic appointments, generally called the 'appointment interval', has been the subject of debate for many years. Doctors all have their own preferences, based either on what they were taught in their orthodontic specialty programs or on community norms. Little evidence has been presented in the orthodontic literature to support these biases. The appointment interval may influence tooth alignment rates and treatment time along with other variables, such as periodontal status. Accelerating orthodontic tooth movement can significantly reduce treatment duration and the risk of side-effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's Hospital
        • Contact:
          • Martyn Cobourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects should:

  1. be aged 12-18 years old;
  2. present with a crowded lower arch that requires orthodontic tooth alignment with a fixed appliance;
  3. be medically fit and healthy (absence of systemic diseases);
  4. have normal weight (according to body mass index measurements BMI);
  5. have permanent dentition;
  6. have lower incisor irregularity of 5-12 mm;
  7. not having complete overbite;
  8. be either extraction or non-extraction cases;
  9. be able to give informed consent.

Exclusion Criteria:

  1. Subjects who have received fixed orthodontic treatment before.
  2. Subjects who will be participating in any other intervention trials.
  3. Subjects with reported nickel allergy.
  4. Subjects who have received antibiotic therapy in the previous six months, or who have any history of juvenile periodontal disease.
  5. Subjects who have lower incisor extracted tooth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Two-week appointment interval group
Orthodontic patients who come to tighten their braces every 2-weeks.
Other: appointment interval
To change the appointment interval for one group and keep the standard interval for the other group by measuring alignment duration, measured as days needed to align the teeth using full-arch fixed appliances
OTHER: Eight-week appointment interval group
Orthodontic patients who come to tighten their braces every every 8-weeks.
Other: appointment interval
To change the appointment interval for one group and keep the standard interval for the other group by measuring alignment duration, measured as days needed to align the teeth using full-arch fixed appliances

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to completion of alignment.
Time Frame: 4-10 months.
To measure the time taken to achieve orthodontic tooth alignment using fixed appliances in two groups of patients treated with different appointment intervals
4-10 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Level of oral biomarkers
Time Frame: 4-10 months.
In vivo levels of oral biomarkers derived from gingival crevicular fluid in the periodontal ligament and saliva. Biomarkers associated with orthodontic tooth movement and/or periodontitis will be tested, including biomarkers for tissue damage and inflammatory processes, such as Lactate dehydrogenase (LDH) and Aspartate aminotransferase (AST), biomarkers to asses inflammation in orthodontic movement, such as Myeloperoxidase (MPO) , biomarkers for resolution of organic matrix and bone resorption, such as Cathepsin B, biomarkers for periodontal ligament remodelling, such as Matrix Metalloproteinases (MMPs).
4-10 months.
Self-reported pain and discomfort.
Time Frame: 4-10 months.
At each adjustment visit, subjects will be given a prepared discomfort questionnaire to complete over the following week and to be returned at each subsequent visit. This questionnaire records discomfort by means of a 100 mm visual analogue scale (VAS) at 4 hours, 24 hours, 3 days, and 1 week, using the terms 'very comfortable' and 'very uncomfortable' as peripheral weightings (Seymour, 1982). The VAS score is the distance from the left end of the line to the point of the subject's mark, measured to the nearest millimetre.
4-10 months.
Periodontal health.
Time Frame: 4-10 months

Periodontal health will be measured using established Gingival and Plaque indices. The criteria for plaque index as:

0: No plaque

  1. A film of plaque adheres to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using probe on the tooth surface.
  2. Moderate accumulation of soft deposits within the gingival pocket, or the tooth and the gingival margin, which can be seen with the naked eye.
  3. An abundance of soft matter within the gingival pocket and/or the tooth and gingival margin.

The criteria for gingival index as:

0: Normal gingiva.

  1. Mild inflammation: slight change in colour, slight oedema, no bleeding on probing.
  2. Moderate inflammation: moderate glazing, redness, oedema, and hypertrophy, bleeding on probing.
  3. Severe inflammation: marked redness and hypertrophic ulceration, tendency to spontaneous bleeding
4-10 months
Rate of tooth movement
Time Frame: 4-10 months
Rate of tooth alignment will be calculated from serial dental study casts using Little's Irregularity Index, which measures the horizontal linear contact-point displacement of each mandibular incisor from the adjacent tooth and therefore, represents the sum of the five individual displacements (Little, 1975).
4-10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guy's and St Thomas' NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof. Martyn Cobourne, King's College London
  • Principal Investigator: Dr. Guy Carpenter, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRAS Project ID: 255727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Un-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Zenodo (open-access repository).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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