HalitosisPhase 2SmellXNCT01388023
Day Long Prevention of Oral Malodor With a Palatal Patch (SmellX) Containing A Herbal Formula
A Phase 2 study testing herbal formula for fresh breath in people with Halitosis and Gingivitis, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis, Gingivitis
- What is being tested?
- herbal formula for fresh breath
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- random gender
- age
- healthy people
Who cannot join
- used antibiotics in the last three months
- suffer from systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Clinical Study of a Day Long Effect of SmellX Palatal Patch Containing A Herbal Formula on Malodor
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.
Read the detailed description
Oral malodor is a common complaint among dental patients. This condition derives in most cases form the putrefactive activities of oral microorganisms, primarily anaerobic Gram negative bacteria. These bacteria reside on various locations within the oral cavity (e.g. tongue dorsum, interdental space, periodontal pockets, faulty and leaky restorations and tonsils) and breakdown salivary and oral proteins into their amino acid building blocks. Some of these amino acids (e.g. methionine and cysteine) are further metabolized yielding malodorous volatile sulfide compounds (VSC) such as methylmercaptan and hydrogen sulfide.The tongue dorsum and especially its posterior portion are considered the key location for this process. Therefore, the treatment regiment includes in most cases a daily use of tongue scrapers and mouthwashes. Indeed, a recent Cochrane systematic review found tongue scrapers to have short-term efficacy in controlling halitosis.
However, the use of tongue scrapers is unpleasant and induces in many cases a strong gag reflex, and apparently has very little effect on bacterial load of the tongue.
Furthermore, some mouthwashes have been shown to cause adverse side effects such as tooth staining. In a previous study we performed a set of related experiments on a new sustained release delivery system in the form of an adhesive tablet containing an herbal formulation. The adhesive tablet is applied to the palate. This places it right above, and in direct contact with the tongue dorsum, thus allowing a sustained release of the active ingredients directly to the target site. The ingredients of the herbal formulation have been previously shown to reduce malodor production in a salivary incubation assay. We tested the effect of this system on oral malodor production and VSC levels in a young healthy population, and the antimicrobial effect of its active ingredients on three known oral pathogens (Streptoccocus mutans, Porphyromonas gingivalis and Candida albicans. In this study we intend to examine a day long protocol to achieve a relief from oral halitosis for 24 houres.
- Conditions
- Halitosis, Gingivitis
- Being tested
- herbal formula for fresh breath
- Keywords
- SmellX, malodor, halitosis, herbal formulation, natural medicinals, slow release delivery system, gingivitis, Bad Breath
- Medical subject headings
- Halitosis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herbal formula for fresh breathDietary supplement
Also called chlorhexidine, listerine, diclosan
composition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria
| Study group | Role | What they receive |
|---|---|---|
| smellx | Active comparator | test group- SmellX palatal patch with the herbal formula Receives: Dietary Supplement: herbal formula for fresh breath |
| smellx palatal patch | Placebo comparator | negative control group- SmellX palatal patch with out the herbal formula Receives: Dietary Supplement: herbal formula for fresh breath |
| chlorhexidine | Active comparator | poositive control group-mouth wash with chlorhexidine 0.125% Receives: Dietary Supplement: herbal formula for fresh breath |
| listerine | Active comparator | listerine mouth wash Receives: Dietary Supplement: herbal formula for fresh breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hr
Secondary outcomes (1)
reduction of halitosis as measured by judge score
judge score of halitosis on a scale of 1-5 is the gold standart for halitosis measurments. levels lower than base line indicate success in the treatment of halitosis
Measured: 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJan 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HalitosisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Michael M Perez Davidi, DMD, Principal investigator, Hadassah Medical Centers The hebrew university Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388023
- Sponsor's protocol ID
- 1910552HMO-CTIL
- Acronym
- SmellX
- Status last verified
- Nov 2012
- First submitted
- 17 Jan 2008
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17694216Mizrahi 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.
PubMed 15459950Sterer N, Rubinstein Y. Effect of various natural medicinals on salivary protein putrefaction and malodor production. Quintessence Int. 2006 Sep;37(8):653-8.
PubMed 16922026Sterer 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.
PubMed 16822220
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Study of a Day Long Effect of SmellX Palatal Patch Containing A Herbal Formula on Malodor
- ClinicalTrials.gov ID
- NCT01388023
- Acronym / sponsor ID
- SmellX / 1910552HMO-CTIL
- Conditions
- Halitosis, Gingivitis
- Keywords
- SmellX, malodor, halitosis, herbal formulation, natural medicinals, slow release delivery system, gingivitis, Bad Breath
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Oral malodor is a common complaint among dental patients. This condition derives in most cases form the putrefactive activities of oral microorganisms, primarily anaerobic Gram negative bacteria. These bacteria reside on various locations within the oral cavity (e.g. tongue dorsum, interdental space, periodontal pockets, faulty and leaky restorations and tonsils) and breakdown salivary and oral proteins into their amino acid building blocks. Some of these amino acids (e.g. methionine and cysteine) are further metabolized yielding malodorous volatile sulfide compounds (VSC) such as methylmercaptan and hydrogen sulfide.The tongue dorsum and especially its posterior portion are considered the key location for this process. Therefore, the treatment regiment includes in most cases a daily use of tongue scrapers and mouthwashes. Indeed, a recent Cochrane systematic review found tongue scrapers to have short-term efficacy in controlling halitosis.
However, the use of tongue scrapers is unpleasant and induces in many cases a strong gag reflex, and apparently has very little effect on bacterial load of the tongue.
Furthermore, some mouthwashes have been shown to cause adverse side effects such as tooth staining. In a previous study we performed a set of related experiments on a new sustained release delivery system in the form of an adhesive tablet containing an herbal formulation. The adhesive tablet is applied to the palate. This places it right above, and in direct contact with the tongue dorsum, thus allowing a sustained release of the active ingredients directly to the target site. The ingredients of the herbal formulation have been previously shown to reduce malodor production in a salivary incubation assay. We tested the effect of this system on oral malodor production and VSC levels in a young healthy population, and the antimicrobial effect of its active ingredients on three known oral pathogens (Streptoccocus mutans, Porphyromonas gingivalis and Candida albicans. In this study we intend to examine a day long protocol to achieve a relief from oral halitosis for 24 houres.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| smellx | Active comparator | Dietary Supplement: herbal formula for fresh breathtest group- SmellX palatal patch with the herbal formula |
| smellx palatal patch | Placebo comparator | Dietary Supplement: herbal formula for fresh breathnegative control group- SmellX palatal patch with out the herbal formula |
| chlorhexidine | Active comparator | Dietary Supplement: herbal formula for fresh breathpoositive control group-mouth wash with chlorhexidine 0.125% |
| listerine | Active comparator | Dietary Supplement: herbal formula for fresh breathlisterine mouth wash |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- random gender
- age
- healthy people
Key exclusion criteria (2 listed)
- used antibiotics in the last three months
- suffer from systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| herbal formula for fresh breathAlso: chlorhexidine, listerine, diclosancomposition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria | Dietary supplement | chlorhexidine, listerine, smellx, smellx palatal patch |
Primary outcome
reduction of VSC measurements with halimeter
Time frame: 24 hr
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
1 secondary outcome
reduction of halitosis as measured by judge score
Time frame: 24 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
- Background: PubMed 17694216Perez 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.
- Results publication: PubMed 15459950Mizrahi 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.
- Results publication: PubMed 16922026Sterer N, Rubinstein Y. Effect of various natural medicinals on salivary protein putrefaction and malodor production. Quintessence Int. 2006 Sep;37(8):653-8.
- Results publication: PubMed 16822220Sterer 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.
- Dr.Michael Perez DavidiLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael M Perez Davidi, DMD principal investigator
Hadassah Medical Centers The hebrew university Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing herbal formula for fresh breath in people with Halitosis and Gingivitis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of VSC measurements with halimeter (time frame: 24 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01388023, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.