Clinical trial NCT04050657: Appointment Intervals and Orthodontic Tooth Movement
Official title: A Randomized Clinical Trial Investigating the Effect of Appointment Intervals on Orthodontic Tooth Alignment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Treatment
Keywords: orthodontic treatment
alignment
rate of tooth movement
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 46
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to completion of alignment.
timeFrame: 4-10 months.
Secondary outcomes:
measure: Level of oral biomarkers
timeFrame: 4-10 months.
measure: Self-reported pain and discomfort.
timeFrame: 4-10 months.
measure: Periodontal health.
timeFrame: 4-10 months
measure: Rate of tooth movement
timeFrame: 4-10 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's hospital
Study officials:
affiliation: King's College London
name: Prof. Martyn Cobourne
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Dr. Guy Carpenter
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.