Xylitol Clinical Studies for Prevention - Xylitol Dose Study (Gum 1)

ISRCTN ISRCTN73818624
DOI https://doi.org/10.1186/ISRCTN73818624
Secondary identifying numbers 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

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
Email dfrc@u.washington.edu

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study acronymGum 1
Study objectivesIncreasing 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) studiedDental Caries
Intervention4 group design. Control (sorbitol gum) and 3 xylitol gum groups all chewed 12 pellets of gum evenly divided into 4 times per day.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Xylitol
Primary outcome measureReduction in mutans streptococci level in plaque and saliva
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2003
Completion date01/06/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants132
Key inclusion criteriaAdult, male & female, with screening plaque mutans streptococci level greater than 10,000 CFU/ml
Key exclusion criteria1. Gastro-intestinal diseases/problems
2. Phenylalanine intolerant
Date of first enrolment01/03/2003
Date of final enrolment01/06/2004

Locations

Countries of recruitment

  • United States of America

Study participating centre

Dental Public Health Sciences
Seattle, Washington
98195
United States of America

Sponsor information

University of Washington (USA)
University/education

Carol Zuiches
Asst Vice Provost for Research
Office of Sponsored Programs
1100 45th St.
NE, Ste. 300
Seattle, Washington
98105
United States of America

Phone +1 206 543 4043
Email gcsvcs@u.washington.edu
Website http://www.washington.edu/research/osp/index.php
ROR logo "ROR" https://ror.org/00cvxb145

Funders

Funder type

Government

National Institute of Dental and Cranio-facial Research (NIDCR) (USA) - U54 DE14254

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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