Contact information
Type
Scientific
Primary contact
Dr Liana Zoitopoulos
ORCID ID
Contact details
King's College London
Dept. of Community Special Care Dentistry
Caldecot Road
London
SE5 9RW
United Kingdom
+44 (0)20 7346 3480
liana.zoitopoulos@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
King's College Hospital Research Ethics Committee gave approval on the 10th February 2006 (ref: 05/Q0703/234)
Study design
Single blind randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Xylitol-containing chewing gum
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
01/11/2006
Overall trial end date
20/04/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
20/04/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE5 9RW
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
School of Medicine
First Floor
Hodgkin Building
Guy's Campus
London
SE1 9RT
United Kingdom
+44 (0)20 7848 6981
robert.lechler@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Dunhill Medical Trust (UK)
Alternative name(s)
DMT
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22533799
Publication citations
-
Results
Al-Haboubi M, Zoitopoulos L, Beighton D, Gallagher JE, The potential benefits of sugar-free chewing gum on the oral health and quality of life of older people living in the community: a randomized controlled trial., Community Dent Oral Epidemiol, 2012, 40, 5, 415-424, doi: 10.1111/j.1600-0528.2012.00685.x.