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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two-week appointment interval group | Experimental | Orthodontic patients who come to tighten their braces every 2-weeks. |
|
| Eight-week appointment interval group | Other | Orthodontic patients who come to tighten their braces every every 8-weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| appointment interval | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4-10 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Subjects should:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Martyn Cobourne | Contact | 02071888028 | martyn.cobourne@kcl.ac.uk | |
| Dr. Maisa Seppala | Contact | 02071888028 | maisa.seppala@kcl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Martyn Cobourne | King's College London | Principal Investigator |
| Dr. Guy Carpenter | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's hospital | Recruiting | London | se1 9rt | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28113000 | Background | 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. | |
| 18929262 | Background | 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. |
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Un-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion.
Zenodo (open-access repository).
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| 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. | 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
The criteria for gingival index as: 0: Normal gingiva.
| 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). | 4-10 months |