Xylitol Clinical Studies for Prevention - Xylitol Snack Foods among Adults Study (Gum 3)
| ISRCTN | ISRCTN25845456 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25845456 |
| Protocol serial number | U54 DE14254 |
| Sponsor | University of Washington (USA) |
| Funder | National Institute of Dental and Cranio-facial Research (NIDCR) (USA), ref: U54 DE14254 |
- Submission date
- 16/11/2005
- Registration date
- 02/12/2005
- Last edited
- 20/08/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Milgrom
Scientific
Scientific
Dental Public Health Sciences
1959 NE Pacific Street
Rm B-509
Box 357475
Seattle, Washington
98195
United States of America
| Phone | +1 206 685 4183 |
|---|---|
| dfrc@u.washington.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Gum 3 |
| Study objectives | Reduction in mutans strepotococci by xylitol snack foods is equivalent to xylitol chewing gum among adults |
| Ethics approval(s) | University of Washington Internal Review Board - Application#: 05-5945-B 01. Approved 29/03/2005. |
| Health condition(s) or problem(s) studied | Dental Caries |
| Intervention | Please note that this trial was stopped during the recruitment phase due to reconsideration of power calculations and insufficient resources. An alternative approach to gaining the information was used and the results have been published in http://www.ncbi.nlm.nih.gov/pubmed/18267030. Interventions: Two group design with positive control. Equivalence study, xylitol Gummy Bears (10.4 g/day) compared to xylitol chewing gum (10.3 g/day). |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Xylitol |
| Primary outcome measure(s) |
Reduction in mutans streptococci level in plaque |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2006 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 140 |
| Key inclusion criteria | Adult, male & female, with screening plaque mutans streptococci level greater than 10,000 CFU/ml |
| Key exclusion criteria | 1. Gastro-intestinal diseases/problems 2. Phenylalanine intolerant |
| Date of first enrolment | 15/05/2005 |
| Date of final enrolment | 01/04/2006 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Dental Public Health Sciences
Seattle, Washington
98195
United States of America
98195
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
