NCT04050657

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

February 6, 2020

Status Verified

November 1, 2019

Enrollment Period

2.1 years

First QC Date

August 7, 2019

Last Update Submit

February 4, 2020

Conditions

Orthodontic Treatment

Keywords

orthodontic treatmentalignmentrate of tooth movement

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (4)

  • Level of oral biomarkers

    4-10 months.

  • Self-reported pain and discomfort.

    4-10 months.

  • Periodontal health.

    4-10 months

  • Rate of tooth movement

    4-10 months

Study Arms (2)

Two-week appointment interval group

EXPERIMENTAL

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

Other: appointment interval

Eight-week appointment interval group

OTHER

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

Other: appointment interval

Interventions

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

Eight-week appointment interval groupTwo-week appointment interval group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's hospital

London, se1 9rt, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28113000BACKGROUND

  • 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.

    PMID: 18929262BACKGROUND

Study Officials

  • Prof. Martyn Cobourne

    King's College London

    PRINCIPAL INVESTIGATOR

  • Dr. Guy Carpenter

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Martyn Cobourne

CONTACT

02071888028martyn.cobourne@kcl.ac.uk

Dr. Maisa Seppala

CONTACT

02071888028maisa.seppala@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 8, 2019

Study Start

December 1, 2019

Primary Completion

January 1, 2022

Study Completion

May 1, 2022

Last Updated

February 6, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within 6 months of study completion.
Access Criteria
Zenodo (open-access repository).

Locations

GB(1)