Orthodontic TreatmentNCT04050657
Appointment Intervals and Orthodontic Tooth Movement
A study testing appointment interval in people with Orthodontic Treatment, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Orthodontic Treatment
- What is being tested?
- appointment interval
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2019to 1 May 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects should:
- be aged 12-18 years old;
- present with a crowded lower arch that requires orthodontic tooth alignment with a fixed appliance;
- be medically fit and healthy (absence of systemic diseases);
- have normal weight (according to body mass index measurements BMI);
- have permanent dentition;
Show all 10Show fewer
- have lower incisor irregularity of 5-12 mm;
- not having complete overbite;
- be either extraction or non-extraction cases;
- be able to give informed consent.
Who cannot join
- Subjects who have received fixed orthodontic treatment before.
- Subjects who will be participating in any other intervention trials.
- Subjects with reported nickel allergy.
- Subjects who have received antibiotic therapy in the previous six months, or who have any history of juvenile periodontal disease.
- Subjects who have lower incisor extracted tooth.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's hospital
London, se1 9rt
Martyn Cobourne
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontic Treatment
- Being tested
- appointment interval
- Keywords
- orthodontic treatment, alignment, rate of tooth movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appointment intervalOther
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
| Study group | Role | What they receive |
|---|---|---|
| Two-week appointment interval group | Experimental | Orthodontic patients who come to tighten their braces every 2-weeks. Receives: Other: appointment interval |
| Eight-week appointment interval group | Other | Orthodontic patients who come to tighten their braces every every 8-weeks. Receives: Other: appointment interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to completion of alignment.
To measure the time taken to achieve orthodontic tooth alignment using fixed appliances in two groups of patients treated with different appointment intervals
Measured: 4-10 months.
Secondary outcomes (4)
Level of oral biomarkers
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).
Measured: 4-10 months.
Self-reported pain and discomfort.
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.
Measured: 4-10 months.
Periodontal health.
Periodontal health will be measured using established Gingival and Plaque indices. The criteria for plaque index as:
0: No plaque
- 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.
- Moderate accumulation of soft deposits within the gingival pocket, or the tooth and the gingival margin, which can be seen with the naked eye.
- 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.
- Mild inflammation: slight change in colour, slight oedema, no bleeding on probing.
- Moderate inflammation: moderate glazing, redness, oedema, and hypertrophy, bleeding on probing.
- Severe inflammation: marked redness and hypertrophic ulceration, tendency to spontaneous bleeding
Measured: 4-10 months
Rate of tooth movement
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).
Measured: 4-10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Dec 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthodontic TreatmentStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Martyn Cobourne, Principal investigator, King's College LondonDr. Guy Carpenter, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050657
- Sponsor's protocol ID
- IRAS Project ID: 255727
- Status last verified
- Nov 2019
- First submitted
- 7 Aug 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Un-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Saloom HF, Papageorgiou SN, Carpenter GH, Cobourne MT. Impact of Obesity on Orthodontic Tooth Movement in Adolescents: A Prospective Clinical Cohort Study. J Dent Res. 2017 May;96(5):547-554. doi: 10.1177/0022034516688448. Epub 2017 Jan 23.
PubMed 28113000Scott P, DiBiase AT, Sherriff M, Cobourne MT. Alignment efficiency of Damon3 self-ligating and conventional orthodontic bracket systems: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2008 Oct;134(4):470.e1-8. doi: 10.1016/j.ajodo.2008.04.018.
PubMed 18929262
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Investigating the Effect of Appointment Intervals on Orthodontic Tooth Alignment
- ClinicalTrials.gov ID
- NCT04050657
- Acronym / sponsor ID
- IRAS Project ID: 255727
- Conditions
- Orthodontic Treatment
- Keywords
- orthodontic treatment, alignment, rate of tooth movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 8 Aug 2019 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-week appointment interval group | Experimental | Other: appointment intervalOrthodontic patients who come to tighten their braces every 2-weeks. |
| Eight-week appointment interval group | Other | Other: appointment intervalOrthodontic patients who come to tighten their braces every every 8-weeks. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- be aged 12-18 years old;
- present with a crowded lower arch that requires orthodontic tooth alignment with a fixed appliance;
- be medically fit and healthy (absence of systemic diseases);
- have normal weight (according to body mass index measurements BMI);
- have permanent dentition;
Key exclusion criteria (5 listed)
- Subjects who have received fixed orthodontic treatment before.
- Subjects who will be participating in any other intervention trials.
- Subjects with reported nickel allergy.
- Subjects who have received antibiotic therapy in the previous six months, or who have any history of juvenile periodontal disease.
- Subjects who have lower incisor extracted tooth.
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 intervalTo 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, Two-week appointment interval group |
Primary outcome
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 secondary outcomes
Level of oral biomarkers
Time frame: 4-10 months.
Self-reported pain and discomfort.
Time frame: 4-10 months.
Periodontal health.
Time frame: 4-10 months
Rate of tooth movement
Time frame: 4-10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Background: PubMed 28113000Saloom HF, Papageorgiou SN, Carpenter GH, Cobourne MT. Impact of Obesity on Orthodontic Tooth Movement in Adolescents: A Prospective Clinical Cohort Study. J Dent Res. 2017 May;96(5):547-554. doi: 10.1177/0022034516688448. Epub 2017 Jan 23.
- Background: PubMed 18929262Scott P, DiBiase AT, Sherriff M, Cobourne MT. Alignment efficiency of Damon3 self-ligating and conventional orthodontic bracket systems: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2008 Oct;134(4):470.e1-8. doi: 10.1016/j.ajodo.2008.04.018.
- Individual participant dataSharing planned: Yes. Un-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Prof. Martyn Cobourne principal investigator
King's College London
Dr. Guy Carpenter principal investigator
King's College London
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 interval in people with Orthodontic Treatment, run by Guy's and St Thomas' NHS Foundation Trust 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 10 inclusion and 5 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 6 Feb 2020. 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?
Contact Prof. Martyn Cobourne (02071888028, martyn.cobourne@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to completion of alignment. (time frame: 4-10 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04050657, which also lists 2 linked publications.
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 6 Feb 2020.