Appointment Intervals and Orthodontic Tooth Movement

NCT ID: NCT04050657

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2022-05-01

Brief Summary

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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

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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

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Orthodontic Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Two-week appointment interval group

Orthodontic patients who come to tighten their braces every 2-weeks.

Group Type EXPERIMENTAL

appointment interval

Intervention Type OTHER

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

Eight-week appointment interval group

Orthodontic patients who come to tighten their braces every every 8-weeks.

Group Type OTHER

appointment interval

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Martyn Cobourne

Role: PRINCIPAL_INVESTIGATOR

King's College London

Dr. Guy Carpenter

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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Guy's hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Prof. Martyn Cobourne

Role: CONTACT

02071888028

Dr. Maisa Seppala

Role: CONTACT

02071888028

Facility Contacts

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Martyn Cobourne

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28113000 (View on PubMed)

Scott 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.

Reference Type BACKGROUND
PMID: 18929262 (View on PubMed)

Other Identifiers

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IRAS Project ID: 255727

Identifier Type: -

Identifier Source: org_study_id

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