Xylitol Clinical Studies for Prevention - Xylitol Dose Study (Gum 1)
| ISRCTN | ISRCTN73818624 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73818624 |
| Protocol serial number | U54 DE14254 |
| Sponsor | University of Washington (USA) |
| Funder | National Institute of Dental and Cranio-facial Research (NIDCR) (USA) - U54 DE14254 |
- Submission date
- 16/11/2005
- Registration date
- 02/12/2005
- Last edited
- 10/09/2009
- 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
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 | +1 206 543 4043 |
|---|---|
| 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 1 |
| Study objectives | Increasing reduction in mutans streptococci level in plaque and saliva to increasing dose of xylitol use |
| Ethics approval(s) | University of Washington Internal Review Board - Application #: 02-4021-B 02. Approved 02/01/2003. |
| Health condition(s) or problem(s) studied | Dental Caries |
| Intervention | 4 group design. Control (sorbitol gum) and 3 xylitol gum groups all chewed 12 pellets of gum evenly divided into 4 times per 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 and saliva |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 132 |
| 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 | 01/03/2003 |
| Date of final enrolment | 01/06/2004 |
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2006 | Yes | No |
