The safety and efficacy of an herbal chlorhexidine gel on bad breath caused by oral bacteria
| ISRCTN | ISRCTN74655176 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74655176 |
| Secondary identifying numbers | 17-33143 |
- Submission date
- 26/07/2017
- Registration date
- 24/10/2017
- Last edited
- 11/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Public
Rainforest Nutritionals Inc.
9201 Leesville Rd
Suite 120C
Raleigh
27613
United States of America
 ORCID ID |
0000-0002-4125-4272 |
|---|
Scientific
2999 NE 191st Street #804
Aventura
33180
United States of America
Study information
| Study design | Single-center randomised double-blind placebo-controlled interventional investigation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | A double-blind placebo controlled study to determine the effectiveness of a new oral gel for halitosis |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 30/05/2017 |
| Completion date | 31/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 28/04/2018 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Florida
South Miami
33143
United States of America
Sponsor information
Industry
9201 Leesville Rd
Suite 120C
Raleigh
27613
United States of America
| Phone | 9193245925 |
|---|---|
| paul@rainforest-inc.com |
Hospital/treatment centre
2999 NE 191st Street #804
Aventura
33180
United States of America
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Anticipated publication date in high-impact peer-reviewed open access journal. |
| IPD sharing plan | 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. |
Editorial Notes
11/01/2018: The overall trial end date has been updated from 28/02/2018 to 31/05/2018. The interventions has been updated. The primary and secondary outcome measures have been updated. The target number of participants have been updated from 15 to 30. The recruitment dates have been updated from 30/10/2017-30/12/2017 to 01/03/2018-28/04/2018. The plain English summary has been updated according to the changes in the study design. The intention to publish date has been updated from 03/05/2018 to 01/06/2018.
09/11/2017: The study is no longer a crossover study and consists of only two groups (randomised controlled trial).
