Condition category
Oral Health
Date applied
16/03/2009
Date assigned
30/04/2009
Last edited
23/01/2013
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 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

http://www.kcl.ac.uk/

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

  1. 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.

Additional files

Editorial Notes