Condition category
Oral Health
Date applied
16/11/2005
Date assigned
02/12/2005
Last edited
20/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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
+1 206 685 4183
dfrc@u.washington.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

U54 DE14254

Study information

Scientific title

Acronym

Gum 3

Study hypothesis

Reduction in mutans strepotococci by xylitol snack foods is equivalent to xylitol chewing gum among adults

Ethics approval

University of Washington Internal Review Board - Application#: 05-5945-B 01. Approved 29/03/2005.

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

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 names

Xylitol

Primary outcome measures

Reduction in mutans streptococci level in plaque

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/05/2005

Overall trial end date

01/04/2006

Reason abandoned

Lack of funding/sponsorship

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

140

Participant exclusion criteria

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

Recruitment start date

15/05/2005

Recruitment end date

01/04/2006

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
98195
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), ref: 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

Publication citations

Additional files

Editorial Notes