Chewing gum and orthodontic pain

ISRCTN	ISRCTN79884739
DOI	https://doi.org/10.1186/ISRCTN79884739
EudraCT/CTIS number	2008-005522-36
Secondary identifying numbers	6631

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 02/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A J Ireland
Scientific

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

Study information

Study design	Randomised interventional and observational cohort study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Chewing gum and orthodontic pain: a randomised interventional and observational cohort study
Study objectives	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(s)	North Somerset and South Bristol Research Ethics Committee, 26/11/2008, ref: 08/H0106/139
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Ibuprofen
Primary outcome measure	Pain
Secondary outcome measures	1. Bond failures, measured following fitting and then following first adjustment 2. Anxiety
Overall study start date	19/10/2009
Completion date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	Planned Sample Size: 1000; UK Sample Size: 1000
Key inclusion criteria	1. Aged 12 - 16 years, either sex 2. Upper and lower fixed orthodontic appliances
Key exclusion criteria	Asthmatic with reaction to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
Date of first enrolment	19/10/2009
Date of final enrolment	01/04/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Bristol

Bristol
BS8 1TH
United Kingdom

Sponsor information

Royal United Hospital Bath NHS Trust (UK)
Hospital/treatment centre

Combe Park
Bath
BA1 3NG
England
United Kingdom

Website	http://www.ruh.nhs.uk/
"ROR"	https://ror.org/058x7dy48

Funders

Funder type

Research organisation

British Orthodontic Society (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2016		Yes	No
Results article	results	01/03/2017		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

02/03/2017: Publication reference added.
03/08/2016: Publication reference added.