NCT02665780

Brief Summary

This study evaluates the short and long term effect of dental cleaning and mouthrinsing for the treatment of bad breath

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

January 25, 2016

Last Update Submit

October 10, 2018

Conditions

Keywords

halitosis, periodontal debridement, chemotherapeutics

Outcome Measures

Primary Outcomes (1)

  • Reduction of oral malodour below threshold

    1, 12, 24 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Periodontal debridement, tongue cleaning, mouth rinsing with 20ml Cetylpyridium Chloride daily for 24 weeks

Procedure: Periodontal debridementOther: Cetylpyridium chloride

Interventions

teeth cleaning

Treatment

mouthrinse

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Organoleptic score of 2 or more, and volatile sulfur compound score of greater than 1.5ng/10ml of hydrogen sulfide and 0.5ng/10ml of methyl mercaptan

You may not qualify if:

  • Moderate to severe periodontal disease, systemic illness or dental disease associated with halitosis, antibiotic use in the past month, need for antibiotic prophylaxis for dental procedures and current smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Halitosis

Interventions

Periodontal DebridementCetylpyridinium

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental ProphylaxisPeriodonticsDentistryPyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Leeann Donnelly, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Dept. Oral Biological and Medical Sciences

Study Record Dates

First Submitted

January 25, 2016

First Posted

January 28, 2016

Study Start

October 1, 2017

Primary Completion

October 10, 2018

Study Completion

October 10, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share