NCT00250289

Brief Summary

the use of a herbal formulation containing sage, echinacea,lavender and mastic gum would prevent oral malodor if delivered in an appropriate delivery system to enable slow release of the active ingredients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

November 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 6, 2010

Status Verified

October 1, 2009

Enrollment Period

1.8 years

First QC Date

November 6, 2005

Last Update Submit

January 5, 2010

Conditions

HalitosisOral MalodorBad Breath

Keywords

malodorhalitosisherbal formulationnatural medicinalsslow release delivery system

Outcome Measures

Primary Outcomes (1)

  • Oral malodor will be measured with a Halimeter monitor and an odor judge before the sticker application and following the application every 7 minutes until the odor level would reach plateau.

Interventions

a mucosal sticker with herbal formulaDEVICE

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • random gender, age and healthy people

You may not qualify if:

  • used antibiotics in the last three months or suffer from systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization,

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • Mizrahi B, Golenser J, Wolnerman JS, Domb AJ. Adhesive tablet effective for treating canker sores in humans. J Pharm Sci. 2004 Dec;93(12):2927-35. doi: 10.1002/jps.20193.

    PMID: 15459950RESULT

Related Links

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael Perez Davidi, DMD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2005

First Posted

November 8, 2005

Study Start

March 1, 2006

Primary Completion

January 1, 2008

Study Completion

September 1, 2008

Last Updated

January 6, 2010

Record last verified: 2009-10

Locations

IL(1)