Condition category
Oral Health
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
03/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A J Ireland

ORCID ID

Contact details

University of Bristol
Division of Child Dental Health
Bristol
BS8 1TH
United Kingdom

Additional identifiers

EudraCT number

2008-005522-36

ClinicalTrials.gov number

Protocol/serial number

6631

Study information

Scientific title

Chewing gum and orthodontic pain: a randomised interventional and observational cohort study

Acronym

Study hypothesis

The null hypothesis in this intention to treat study is that there is no difference between the use of ibuprofen and sugar-free chewing gum in the relief of orthodontic pain in the 3 days following the fitting and then subsequent adjustment of orthodontic fixed appliances. The secondary outcome measure is bracket or wire failure. In addition patient anxiety will be measured following brace fitting and subsequent adjustment as anxiety may affect the perception of pain.

Ethics approval

North Somerset and South Bristol Research Ethics Committee, 26/11/2008, ref: 08/H0106/139

Study design

Randomised interventional and observational cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Oral & Dental

Intervention

The control is ibuprofen and the intervention is sugar-free chewing gum.
Study entry: single randomisation only

Intervention type

Drug

Phase

Phase IV

Drug names

Ibuprofen

Primary outcome measures

Pain

Secondary outcome measures

1. Bond failures, measured following fitting and then following first adjustment
2. Anxiety

Overall trial start date

19/10/2009

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 12 - 16 years, either sex
2. Upper and lower fixed orthodontic appliances

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 1000; UK Sample Size: 1000

Participant exclusion criteria

Asthmatic with reaction to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)

Recruitment start date

19/10/2009

Recruitment end date

01/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 1TH
United Kingdom

Sponsor information

Organisation

Royal United Hospital Bath NHS Trust (UK)

Sponsor details

Combe Park
Bath
BA1 3NG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.ruh.nhs.uk/

Funders

Funder type

Research organisation

Funder name

British Orthodontic Society (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27476354

Publication citations

Additional files

Editorial Notes

03/08/2016: Publication reference added.