Condition category
Oral Health
Date applied
26/07/2017
Date assigned
24/10/2017
Last edited
11/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Publication citations

Additional files

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).