Plain English Summary
Background and study aims
Halitosis (malodor, “bad breath”) is a common, yet socially stigmatizing condition that affects roughly 30-50% of the population. Ninety percent of all cases of halitosis are estimated to come from the oral cavity, and the remainder from the gut microbiome and systemic disease. Halitosis that originates in the oral cavity is caused by volatile sulfur compounds (VSC) such as hydrogen sulfide (H2S) and Methanethiol (CH3SH, “MeSH”), which are byproducts of the sulfur-metabolizing bacteria that reside primarily in periodontal pockets, cheek mucosa and the dorsum (back) of the tongue. The substrates (the surface or material that bacteria grows on) of these bacteria are the sulfur-containing amino acids (e.g. cysteine, methionine) which are commonly found in everyday food sources. Thus, halitosis of oral origin is circadian, rising and falling in combination with ingestion and varying in intensity throughout a 24-hour period. Therefore, the aim of this study is to test the efficacy of an Herbal Chlorhexidine oral gel (HCG) in subjects with chronic oral halitosis to determine the reduction in oral bacteria and associated VSC.
Who can participate?
Adults aged 18 to 70 who have halitosis.
What does the study involve?
Prior to the beginning of the study, participants have tongue scrapings sampled and measured for bacteria and provide breath samples that are measured for odor (volatile sulfur compounds). They are also administered a quality of life questionnaire. Participants are randomly allocated to one of two groups. Those in the first group receive an oral gel containing study constituents (treatment). Those in the second group receive an oral gel without study constituents (placebo or dummy). Both groups are instructed as to how and when to apply the gel to the tongue. Following a one-week application period, all parameters are measured again (e.g. tongue bacteria, breath odor, and questionnaire). Following a one-week period, all participant s parameters are taken again and the measurements compared between treatments.
What are the possible benefits and risks of participating?
Participants may benefit from using the gel as it contains botanical ingredients known for their impact on halitosis so it is anticipated the treatment gel will have a longer lasting and more substantial affect. The treatment gel contains material commonly available in many mouthwashes with side-effects including dry mouth and unpleasant taste.
Where is the study run from?
Periodontal Solutions (USA)
When is the study starting and how long is it expected to run for?
May 2018 to April 2018
Who is funding the study?
Investigator initiated and funded (USA)
Who is the main contact?
Mr Paul Bobrowski
Dr Stephanie Gonzalez
Trial website
Contact information
Type
Public
Primary contact
Mr Paul Bobrowski
ORCID ID
http://orcid.org/0000-0002-4125-4272
Contact details
Rainforest Nutritionals Inc.
9201 Leesville Rd
Suite 120C
Raleigh
27613
United States of America
Type
Scientific
Additional contact
Dr Stephanie Gonzalez
ORCID ID
Contact details
2999 NE 191st Street #804
Aventura
33180
United States of America
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17-33143
Study information
Scientific title
A double-blind placebo controlled study to determine the effectiveness of a new oral gel for halitosis
Acronym
Study hypothesis
Intervention with an herbal-chlorhexidine gel applied to the dorsum of the tongue reduces volatile sulfur compounds (VSC) and oral malodor better than tongue brushing alone.
Ethics approval
Not provided at time of registration
Study design
Single-center randomised double-blind placebo-controlled interventional investigation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Halitosis (malodor)
Intervention
Current interventions as of 11/01/2018:
Participants are recruited from a pool of current patients as well as new. Baseline data is recorded. This includes: organoleptic measurements, volatile sulfur compound (VSC) [H2S, MeSH] levels, tongue scraping (microbiota) and self-assessment survey.
Participants are randomly allocated to receive either treatment or placebo (unmarked, coded) for a 7-day period and assessments compared to baseline. The treatment consists of a Herbal-Chlorhexidine gel with tongue-scraping. The placebo consists of a flavored gel with tongue-scraping.
Analysis includes changes in microbiota, organoleptic indices, volatile sulfur compound (VSC) levels, and quality of life (QOL) ratings.
Previous interventions:
Participants are recruited from a pool of current patients as well as new. Baseline data is recorded. This includes: organoleptic measurements, volatile sulfur compound (VSC) [H2S, MeSH] levels, tongue scraping (microbiota) and self-assessment survey.
Participants are randomly allocated to receive either treatment or placebo (unmarked, coded) for a 7-day period and assessments compared to baseline. The treatment consists of a Herbal-Chlorhexidine gel with tongue-scraping. The placebo consists of a flavored gel with tongue-scraping. After a one-week wash-out period, participants are placed in a different treatment group and process repeated.
Analysis includes changes in microbiota, organoleptic indices, volatile sulfur compound (VSC) levels, and quality of life (QOL) ratings. Each analysis is repeated after each intervention period.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Current outcome measures as of 11/01/2018:
1. Microbiota is measured by standard AOAC methodology (e.g. plate count) via a registered independent laboratory from tongue scrapings at the beginning and end of the trial period (Days 1 and 7).
2. VSC (GC) is measured using a halimeter (e.g. OralChroma) at the beginning and end of the trial period (Days 1 and 7).
3. Organoleptic is measured using the gastight syringe method of Kim et al (2009) at the beginning and end of the trial period (Days 1 and 7).
Previous outcome measures:
1. Microbiota is measured by standard AOAC methodology (e.g. plate count) via a registered independent laboratory from tongue scrapings at days one, eight, 15 and 22
2. VSC (GC) is measured using a halimeter (e.g. OralChroma) at days one, eight, 15 and 22
3. Organoleptic is measured using the gastight syringe method of Kim et al (2009) at days one, eight, 15 and 22
Secondary outcome measures
Current secondary outcome measures as of 11/01/2018:
Quality of life is assessed using a modified Halitosis Associated Life Quality Test (HALT) at the beginning and end of the trial period (Days 1 and 7).
Previous secondary outcome measures:
Quality of life is assessed using a modified Halitosis Associated Life Quality Test (HALT) questionnaire at days one, eight, 15 and 22.
Overall trial start date
30/05/2017
Overall trial end date
31/05/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Informed consent
2. Availability at the investigational site at the specified study intervals and sampling times
3. Baseline organoleptic malodor score of >2
4. Baseline total VSC > the threshold level of GC (OralChroma®, Breathtron®, Halimeter®)
5. > 20 remaining permanent teeth (tooth brushing > qd)
6. Good oral hygiene/dental health
7. Ability to safely fast prior to at the specified study intervals and sampling times
8. Male and Females 18-70
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. History of infectious disease
2. Current use of antibiotics, antimicrobials or during the trial period
3. Severe periodontal disease or extensive caries
4. Periodontal pocket > 6 mm in depth
5. Consumption of pre-, pro-biotics or other target gut microbiome supplements
6. Smoker
7. Allergies to any of the treatment constituents
Recruitment start date
01/03/2018
Recruitment end date
28/04/2018
Locations
Countries of recruitment
United States of America
Trial participating centre
Periodontal Solutions
7600 S Red Rd Ste 216
Florida
South Miami
33143
United States of America
Sponsor information
Organisation
Rainforest Nutritionals Inc
Sponsor details
9201 Leesville Rd
Suite 120C
Raleigh
27613
United States of America
9193245925
paul@rainforest-inc.com
Sponsor type
Industry
Website
Organisation
Stephanie Gonzalez, DMD, MS
Sponsor details
2999 NE 191st Street #804
Aventura
33180
United States of America
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Anticipated publication date in high-impact peer-reviewed open access journal.
IPD sharing statement:
The datasets generated during and/or analyzed during the current study will be available upon request from Paul Bobrowski email: paul@rainforest-inc.com and limited to current researchers in the field and redacted.
Intention to publish date
01/06/2018
Participant level data
Available on request
Results - basic reporting
Publication summary