Gum chewing and oral health in older people in the community
| ISRCTN | ISRCTN65719588 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65719588 |
| Secondary identifying numbers | N/A |
- 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
Scientific
King's College London
Dept. of Community Special Care Dentistry
Caldecot Road
London
SE5 9RW
United Kingdom
| Phone | +44 (0)20 7346 3480 |
|---|---|
| liana.zoitopoulos@kcl.ac.uk |
Study information
| Study design | Single blind randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| 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 | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Xylitol-containing chewing gum |
| Primary outcome measure | 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 study start date | 01/11/2006 |
| Completion date | 20/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
King's College London
London
SE5 9RW
United Kingdom
SE5 9RW
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
School of Medicine
First Floor, Hodgkin Building
Guy's Campus
London
SE1 9RT
England
United Kingdom
| Phone | +44 (0)20 7848 6981 |
|---|---|
| robert.lechler@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/ |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Dunhill Medical Trust (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Dunhill Medical Trust, DMT
- Location
- United Kingdom
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 | 01/10/2012 | Yes | No |
