The safety and efficacy of an herbal chlorhexidine gel on bad breath caused by oral bacteria

A double-blind placebo controlled study to determine the effectiveness of a new oral gel for halitosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74655176

Enrollment

Registered

2017-10-24

Start date

2018-03-01

Completion date

Unknown

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Halitosis (malodor) Oral Health Halitosis (malodor)

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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;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

Exclusion criteria

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 ;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

Design outcomes

Primary

Measure	Time frame
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;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	—

Measure

Time frame

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;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

Measure	Time frame
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. ;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.	—

Measure

Time frame

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. ;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.

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Countries

United States of America

Contacts

Public ContactPaul;Paul Bobrowski;Bobrowski

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Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026