Gum chewing and oral health in older people in the community

ISRCTN	ISRCTN65719588
DOI	https://doi.org/10.1186/ISRCTN65719588
Protocol serial number	N/A
Sponsor	King's College London (UK)
Funder	Dunhill Medical Trust (UK)

Submission date: 16/03/2009
Registration date: 30/04/2009
Last edited: 23/01/2013

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 Liana Zoitopoulos
Scientific

King's College London
Dept. of Community Special Care Dentistry
Caldecot Road
London
SE5 9RW
United Kingdom

Phone	+44 (0)20 7346 3480
Email	liana.zoitopoulos@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Single blind randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effect of gum chewing on the oral health and quality of life of older people living in the community: a single blind, randomised controlled study
Study objectives	The study is investigating whether the daily use of xylitol-containing chewing gum provides oral health benefits for older people living in the community, over and above routine oral care practices and usual dental attendance.
Ethics approval(s)	King's College Hospital Research Ethics Committee gave approval on the 10th February 2006 (ref: 05/Q0703/234)
Health condition(s) or problem(s) studied	Oral health
Intervention	Regular use (15 minutes, twice a day) of xylitol chewing gum versus no intervention. The test group is given the chewing gum to take home and use twice a day for 6 months. The follow up is after 6 months. The baseline visit and follow-up last around 45 minutes each. The control group is also seen after six months but are not given any intervention in the meantime.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Xylitol-containing chewing gum
Primary outcome measure(s)	Improved oral health, determined by: 1. Caries increment (decayed, missing and filled coronal surfaces) 2. Root caries index increment 3. Plaque Index Increment 4. Change in prevalence of soft tissue pathology 5. Denture debris index increment Collected during the follow-up visit at 6 months.
Key secondary outcome measure(s)	1. Changes in salivary levels of caries-associated microorganisms (mutans group streptococci, lactobacilli, yeast) 2. Change in stimulated whole salivary flow rate (ml/min) 3. change in oral health related quality of life (OHIP-14) 4. Experience of side-effects and adverse events 5. To ascertain attitudes to chewing gum as an adjunct to oral care Collected during the follow-up visit at 6 months.
Completion date	20/04/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. Aged 60 years and over, either sex 2. Dentate: with a minimum of 6 natural teeth 3. Living independently in the community
Key exclusion criteria	1. Living in residential care 2. Taken antibiotics during the 4 weeks prior to commencing the trial 3. Not able to understand and give informed consent
Date of first enrolment	01/11/2006
Date of final enrolment	20/04/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

King's College London

London
SE5 9RW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes