NCT00004640

Brief Summary

The purpose of this study is to determine if regular rinsing with chlorhexidine is effective as a long-term preventive method for reducing the incidence of tooth loss in low income older adults. The true end-point of the study is tooth loss after five years of regular rinsing with chlorhexidine or a placebo; surrogate endpoints are periodontal disease, root and coronal decay.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,101

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 1998

Longer than P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 17, 1999

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 1999

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

10 years

First QC Date

September 17, 1999

Last Update Submit

June 19, 2012

Conditions

Tooth LossPeriodontal DiseaseTooth Decay

Keywords

AgingElderlyPeriodontal DiseaseDental CariesFluorideAntibacterial rinseChlorhexidineTooth Mortality

Outcome Measures

Primary Outcomes (1)

  • regular rinsing with chlorhexidine is effective method for reducing the incidence of tooth loss in low income older adults.

    five years of regular rinsing

Interventions

Chlorhexidine rinseDRUG

chlorhexidine solution on tooth loss in low income

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at entry 60-75
  • Four or more natural teeth
  • No preventive dental visits in the past 18 months
  • Scores \> or = 60 on a measure of oral health self-efficacy (max possible=100)
  • willing to participate in a five-year study
  • willing to use rinses on a prescribed regimen and to return for yearly cleaning and exam appointments.

You may not qualify if:

  • Not having a phone at home for follow-up calls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Washington

Seattle, Washington, 98195-7134, United States

Location

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Tooth LossPeriodontal DiseasesDental Caries

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesTooth Demineralization

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 1999

First Posted

September 20, 1999

Study Start

May 1, 1998

Primary Completion

May 1, 2008

Study Completion

October 1, 2008

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

CA(1)US(1)