Xylitol clinical studies for prevention: In-school xylitol gummy bear snack study
| ISRCTN | ISRCTN63160504 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63160504 |
| 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
- 07/02/2008
- Registration date
- 26/02/2008
- Last edited
- 30/07/2008
- 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
Room B-509
Box 357475
Seattle
98195
United States of America
| Phone | +1 206 543 4043 |
|---|---|
| dfrc@u.washington.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randmised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | School-based xylitol gummy bears snacks: a randomized controlled trial |
| Study objectives | Consumption of xylitol gummy snacks reduces S. mutans and Lactobacillus spp. levels |
| Ethics approval(s) | University of Washington Internal Review Board. Date of approval: 27 March 2007 (ref: HS # 07-4857-B 01) |
| Health condition(s) or problem(s) studied | Dental caries |
| Intervention | Randomisation was carried out at the level of individuals. Gummy bear snacks were packaged by the unit-dose and labeled specific to the students ID number which corresponded with the individual randomization. Three-group design: Group 1: Xylitol gummy bears, 11.7 g/day xylitol Group 2: Xylitol gummy bears, 15.6 g/day xylitol Group 3: Maltitol gummy bear (control) All groups consumed gummy bears 3 times/day for 6 weeks in the classroom during school hours only. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | xylitol |
| Primary outcome measure(s) |
S. mutans and Lactobacillus spp. levels in plaque samples at enrollment (baseline) and 6 weeks (end of study). |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 153 |
| Key inclusion criteria | Children attending First through Fifth grade at two elementary schools in rural Washington State, USA |
| Key exclusion criteria | Children with gastrointestinal problems |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/06/2007 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Dental Public Health Sciences
Seattle
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 | 25/07/2008 | Yes | No |
