NCT01388023

Brief Summary

In a previous study the prevention of halitosis by the herbal formula and delivery system (SmellX), were established both in vitro and clinicaly. The duration of relief was established as long as 8 hours. In this study the investigators intend examine the day long efficacy of SmellX.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2

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

Study Start

First participant enrolled

January 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

4.8 years

First QC Date

January 17, 2008

Last Update Submit

November 19, 2012

Conditions

HalitosisGingivitis

Keywords

SmellXmalodorhalitosisherbal formulationnatural medicinalsslow release delivery systemgingivitisBad Breath

Outcome Measures

Primary Outcomes (1)

  • reduction of VSC measurements with halimeter

    volatile solfur compounds can be measured with a halimeter as an indication of halitosis. decrease of vsc value from base line indicates success in reducing halitosis

    24 hr

Secondary Outcomes (1)

  • reduction of halitosis as measured by judge score

    24 hr

Study Arms (4)

smellx

ACTIVE COMPARATOR

test group- SmellX palatal patch with the herbal formula

Dietary Supplement: herbal formula for fresh breath

smellx palatal patch

PLACEBO COMPARATOR

negative control group- SmellX palatal patch with out the herbal formula

Dietary Supplement: herbal formula for fresh breath

chlorhexidine

ACTIVE COMPARATOR

poositive control group-mouth wash with chlorhexidine 0.125%

Dietary Supplement: herbal formula for fresh breath

listerine

ACTIVE COMPARATOR

listerine mouth wash

Dietary Supplement: herbal formula for fresh breath

Interventions

herbal formula for fresh breathDIETARY_SUPPLEMENT

composition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria

Also known as: chlorhexidine, listerine, diclosan
chlorhexidinelisterinesmellxsmellx palatal patch

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • random gender
  • age
  • healthy people

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization,

Jerusalem, 49453, Israel

Location

Related Publications (4)

  • Perez Davidi M, Beyth N, Sterer N, Feuerstein O, Weiss EI. Effect of liquid-polish coating on in vivo biofilm accumulation on provisional restorations: part 1. Quintessence Int. 2007 Jul-Aug;38(7):591-6.

    PMID: 17694216BACKGROUND

  • 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

  • Sterer N, Rubinstein Y. Effect of various natural medicinals on salivary protein putrefaction and malodor production. Quintessence Int. 2006 Sep;37(8):653-8.

    PMID: 16922026RESULT

  • Sterer N. Antimicrobial effect of mastic gum methanolic extract against Porphyromonas gingivalis. J Med Food. 2006 Summer;9(2):290-2. doi: 10.1089/jmf.2006.9.290.

    PMID: 16822220RESULT

Related Links

MeSH Terms

Conditions

HalitosisGingivitis

Interventions

ChlorhexidineListerinediclosan

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Michael M Perez Davidi, DMD

    Hadassah Medical Centers The hebrew university Jerusalem

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2008

First Posted

July 6, 2011

Study Start

January 1, 2008

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

IL(1)