Condition category
Oral Health
Date applied
16/11/2005
Date assigned
02/12/2005
Last edited
10/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Milgrom

ORCID ID

Contact details

Dental Public Health Sciences
1959 NE Pacific Street
Rm B-509
Box 357475
Seattle
Washington
98195
United States of America
+1 206 543 4043
dfrc@u.washington.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

U54 DE14254

Study information

Scientific title

Acronym

Gum 1

Study hypothesis

Increasing reduction in mutans streptococci level in plaque and saliva to increasing dose of xylitol use

Ethics approval

University of Washington Internal Review Board - Application #: 02-4021-B 02. Approved 02/01/2003.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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 names

Xylitol

Primary outcome measures

Reduction in mutans streptococci level in plaque and saliva

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2003

Overall trial end date

01/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Adult, male & female, with screening plaque mutans streptococci level greater than 10,000 CFU/ml

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

132

Participant exclusion criteria

1. Gastro-intestinal diseases/problems
2. Phenylalanine intolerant

Recruitment start date

01/03/2003

Recruitment end date

01/06/2004

Locations

Countries of recruitment

United States of America

Trial participating centre

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

Sponsor information

Organisation

University of Washington (USA)

Sponsor details

Carol Zuiches
Asst Vice Provost for Research
Office of Sponsored Programs
1100 45th St.
NE
Ste. 300
Seattle
Washington
98105
United States of America
+1 206 543 4043
gcsvcs@u.washington.edu

Sponsor type

University/education

Website

http://www.washington.edu/research/osp/index.php

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results http://www.ncbi.nlm.nih.gov/pubmed/16434738

Publication citations

  1. Results

    Milgrom P, Ly KA, Roberts MC, Rothen M, Mueller G, Yamaguchi DK, Mutans streptococci dose response to xylitol chewing gum., J. Dent. Res., 2006, 85, 2, 177-181.

Additional files

Editorial Notes