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
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
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28248619