Condition category
Oral Health
Date applied
22/12/2013
Date assigned
26/06/2014
Last edited
11/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Orthodontic treatment is a type of dentist treatment which aims to improve the appearance, position and function of teeth that are crooked or in an abnormal position in the mouth. One such treatment is fitting an orthodontic brace for a set period of time to correct the positioning of the teeth or to straighten them. Wearing orthodontic braces, however, can make maintaining good oral hygiene a challenge, with the wires and attachments making it difficult for the toothbrush to gain access to the teeth. This can result in the build-up of plague and debris, which, in turn, can lead to gingivitis (gum inflammation and bleeding), and damage to the teeth such as decalcification around brace attachments. It is therefore important to measure the amount of plague in these more difficult to access areas. It has been suggested that powered toothbrushes are more effective in preventing gingivitis than manual toothbrushes. Such an advantage would be of particular interest to people who wear orthodontic braces. However there is insufficient evidence to support the comparative effectiveness of powered toothbrushes in reducing gingivitis in these patients. Here, we aim to address this by comparing the levels of plaque control, gingival health and enamel decalcification in patients wearing braces using either a powered toothbrush or a manual one.

Who can participate?
Patients aged 12-18 years who require fixed braces for their teeth.

What does the study involve?
Participants will be randomly allocated to one of two tooth brushing groups (a control and an intervention group). Plaque score (a measure of how much plaque is on the teeth) and gum health measurements (assessing inflammation, pockets around the teeth and bleeding) for each patient are taken before the start of treatment. Both groups are treated with fixed orthodontic braces. All patients in the control group are given the same type of manual toothbrush and all patients in the intervention group are given the same type of powered toothbrush. Patients are shown how to keep their teeth clean using their allocated toothbrush. All patients have brush for two minutes each morning and evening. No other oral hygiene devices, mouth rinses or dentifrices can be used. All subjects have their plaque and gum health measured at 1, 6 and 12 months with the final scoring being at the debond (removal of braces) appointment. Enamel decalcification measurements are also taken at the start and at debond appointments.

What are the possible benefits and risks of participating?
Risks associated with orthodontic treatment and include decay or decalcification due to decreased oral hygiene or increased sugar intake, gum disease due to decreased oral hygiene, root shortening (resorption) and relapse. Tooth brushing either manual or electric form part of a persons' normal daily oral hygiene regime and the risks are minimal.

Where is the study run from?
The Orthodontic Department, Barts and The London School of Medicine and Dentistry (UK)

When is the study starting and how long is it expected to run for?
February 2014 to February 2016

Who is funding the study?
London Alpha Omega Charitable Trust & Barts Health Orthodontic department (UK)

Who is the main contact?
Dr Ama Johal
a.s.johal@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ama Johal

ORCID ID

Contact details

Barts and The London School of Medicine and Dentistry
Queen Mary University of London
New Road
London
E1 2BA
United Kingdom
+44 20 7882 8651
a.s.johal@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4/009127 QM

Study information

Scientific title

Manual versus powered tooth brushing in orthodontic patients: a randomised controlled trial

Acronym

Study hypothesis

1. There is a difference in the levels of plaque control, gum health and risk of damage to tooth enamel (decalcification) when comparing powered toothbrushes with manual toothbrushes in patients with braces (orthodontic patients).
2. A patient's short term plaque control and gingival health can predict the risk of damage to their tooth enamel at the end of treatment.

The null hypotheses are:
1. There is no significant difference in plaque control levels, gum health and damage to tooth enamel rates in patients using powered tooth brushing in comparison to those using manual tooth brushes in the short term or long term.
2. A patients short term plaque control and gum health cannot predict tooth enamel damage risk at the end of treatment.

Ethics approval

Bloomsbury NRES Committee London, 27/02/2014, ref: 14/LO/0003

Study design

Prospective randomised single blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Best type of toothbrush for orthodontic patients

Intervention

Patients are randomised to two groups: intervention and control groups
The intervention group will be instructed to use a powered toothbrush, twice a day for the whole period they are in braces, whereas the control group will use a manual toothbrush, twice a day for the whole period they are in braces.
Participants in both groups are followed up 1 month after fixed appliance placement (T1), 6 months (T2), 12 months (T3) months and at debond (T4).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To compare the means of the two groups with respect to the plaque and gingivitis indices at 1, 6, 12 months and at the debond appointment. Levels of decalcification will also be measured at the debond appointment

Secondary outcome measures

Whether the results at 1 month can serve as a predictor of how a patients plaque control and gum health will be like, as well as be a forecaster of enamel decalcification at the end of treatment.

Overall trial start date

03/02/2014

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 12-18 years at start of treatment
2. Upper and lower preadjusted Edgewise appliances
3. Brushing at least once a day
4. Good general health
5. Non smokers

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

92

Participant exclusion criteria

1. Learning difficulties or special needs
2. Poor periodontal health (including the presence of supra and subgingival calculus or periodontal pocketing as determined by BPE codes 2, 3 or 4)
3. Oral prophylaxis in previous 4 weeks
4. Use of antibacterial mouth rinses

Recruitment start date

03/02/2014

Recruitment end date

21/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts and The London School of Medicine and Dentistry
London
E1 2BA
United Kingdom

Sponsor information

Organisation

Queen Mary, University of London (UK)

Sponsor details

c/o Gerry Leonard
Joint Research Office
5 Walden Street
London
E1 2AN
United Kingdom
+44 20 7882 7250
sponsorsrep@bartshealth.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

London Alpha Omega Charitable Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Barts Health NHS Trust (UK) - Orthodontic department

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

30/09/2019

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/07/2016: The overall trial end date has been updated from 08/02/2016 to 30/09/2016 and the recruitment end date has been updated from 08/02/2016 to 21/12/2016. In addition, the ethics approval information has been added, as well as the publication and dissemination plan.