NCT00393055

Brief Summary

The purpose of the trial is to determine the extent to which daily use of xylitol lozenges reduces the appearance of new caries lesions in adults who tend to experience such lesions (i.e., caries-active adults).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
709

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2007

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 12, 2011

Status Verified

September 1, 2011

Enrollment Period

4.4 years

First QC Date

October 25, 2006

Last Update Submit

September 9, 2011

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • combined root and coronal D2FS (dental caries) increment

    3 year

Secondary Outcomes (3)

  • combined root and coronal D12FS (dental caries) increment

    three year

  • separate root and coronal D12FS (dental caries) increments

    3 years

  • association of lozenge use with D12FS (dental caries) in control group only

    3 years

Study Arms (2)

xylitol lozenge

EXPERIMENTAL

1g xylitol lozenge. Five/day, dissolved in mouth

Dietary Supplement: xylitol

inactive lozenge

PLACEBO COMPARATOR

1g placebo lozenge. Five/day, dissolved in mouth

Dietary Supplement: inactive lozenge

Interventions

xylitolDIETARY_SUPPLEMENT

1g xylitol lozenges to be dissolved in mouth. Five lozenges daily for three years

xylitol lozenge
inactive lozengeDIETARY_SUPPLEMENT

1g inactive lozenge, dissolved in mouth. Five/day for three years

Also known as: placebo
inactive lozenge

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 25-80
  • at least one caries lesion in year prior to enrollment
  • at least 12 teeth without crowns
  • no allergies to xylitol or aspartame
  • anticipate remaining in area for 3 years

You may not qualify if:

  • or more caries lesions in year prior to enrollment
  • currently receiving long-term antibiotic therapy
  • history of head and neck radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0111, United States

Location

University of North Carolina School of Dentistry

Chapel Hill, North Carolina, 27599-7450, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (4)

  • Brown JP, Amaechi BT, Bader JD, Gilbert GH, Makhija SK, Lozano-Pineda J, Leo MC, Chen C, Vollmer WM; X-ACT Trial Collaborative Group. Visual scoring of non cavitated caries lesions and clinical trial efficiency, testing xylitol in caries-active adults. Community Dent Oral Epidemiol. 2014 Jun;42(3):271-8. doi: 10.1111/cdoe.12082. Epub 2013 Nov 8.

    PMID: 24205951DERIVED

  • Ritter AV, Bader JD, Leo MC, Preisser JS, Shugars DA, Vollmer WM, Amaechi BT, Holland JC. Tooth-surface-specific effects of xylitol: randomized trial results. J Dent Res. 2013 Jun;92(6):512-7. doi: 10.1177/0022034513487211. Epub 2013 Apr 15.

    PMID: 23589387DERIVED

  • Bader JD, Vollmer WM, Shugars DA, Gilbert GH, Amaechi BT, Brown JP, Laws RL, Funkhouser KA, Makhija SK, Ritter AV, Leo MC. Results from the Xylitol for Adult Caries Trial (X-ACT). J Am Dent Assoc. 2013 Jan;144(1):21-30. doi: 10.14219/jada.archive.2013.0010.

    PMID: 23283923DERIVED

  • Bader JD, Shugars DA, Vollmer WM, Gullion CM, Gilbert GH, Amaechi BT, Brown JP. Design of the xylitol for adult caries trial (X-ACT). BMC Oral Health. 2010 Sep 29;10:22. doi: 10.1186/1472-6831-10-22.

    PMID: 20920261DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Xylitol

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • James D Bader, DDS MPH

    UNC School of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Res Prof

Study Record Dates

First Submitted

October 25, 2006

First Posted

October 26, 2006

Study Start

January 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 12, 2011

Record last verified: 2011-09

Locations

US(3)