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A Clinical Study to Examine the Effects of an Experimental Toothpaste Compared to a Regular Fluoride Toothpaste on Breath Odor in a Population With Gingivitis

Primary Purpose

Halitosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Experimental Dentifrice

Reference Dentifrice

About this trial

This is an interventional treatment trial for Halitosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
Participant who is willing and able to comply with scheduled visits, product usage requirements, study procedures and lifestyle restrictions.
Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history (for example, a medical condition or medication confirmed to contribute to xerostomia),or upon oral examination, that would impact the participant's safety, wellbeing or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
Participant with generally good oral health that fulfil all of the following:
1. Having at least 20 natural (vital) teeth.
2. Good oral health without lesions in the oral cavity (including the tongue) that could interfere with the study evaluations.
3. Having clinically diagnosed, plaque-induced gingivitis defined as having 10-30% bleeding sites from the bleeding on probing assessment.
4. At Screening (Visit 1) and prior to brushing with assigned dentifrice at Baseline (Visit 2) participants must provide 2 samples of mouth air, which must have a mean hydrogen sulfide concentration greater than 150ppb. There must be less than or equal to (<=)500ppb difference between the values measured at screening and baseline (pre-brushing).
5. At Baseline (Visit 2), prior to brushing with assigned dentifrice participants must provide a breath sample with a mean organoleptic score greater than or equal to (>=)2.

Exclusion Criteria:

Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of study entry and/or during study participation or who has previously been enrolled in this study.
Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
A Participant who is pregnant (self-reported) or intending to become pregnant during the study.
Participant who is breastfeeding.
Participant who habitually smokes, uses tobacco products or who vapes.
Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
Participant who is unwilling or, in the opinion of the investigator or medically qualified designee, unable to comply with the requirements and/or Lifestyle Considerations of the study.
Participant with a recent history (within the last year) of alcohol or other substance abuse.
General medical exclusions:
1. Participant with a medical history that may prevent the Participant from participating in the study until study conclusion.
2. Participant with, or having recent history of, bronchitis, tonsillitis or sinusitis (within 6 weeks) or any other systemic condition that can cause oral malodor for example, xerostomia, chronic acid reflux, Type 1 diabetes, Crohn's disease, celiac disease or liver/kidney conditions.
3. Participant with a significant infectious disease, such as hepatitis, COVID-19, flu, respiratory infection, tuberculosis, or any other condition which can be transmitted in saliva or salivary aerosols which, in the opinion of the examiner, could endanger the organoleptic assessors.
4. Participant with any condition that impacts gum health (for example, Type 2 Diabetes).
General medication exclusions:
1. Participant using any antibiotic medication within 14 days prior to screening or at any time during the study.
2. Participant using chlorhexidine, cetylpyridinium chloride (CPC) or stannous fluoride containing mouthwash or dentifrice within 14 days prior to Visit 2 or between Visit 2 and 3.
3. Participant taking medications which may impact oral mouth odor (for example, Diazepam, Alprazolam, Lorazepam and so on).
General oral exclusions:
1. Participant with orthodontic or prosthetic appliances (fixed or removable), including dental implants.
2. Participant having had professional dental cleaning (oral prophylaxis) within 3 months prior to the screening visit or at any time during the study.
3. Participant with signs of active periodontal disease (with probing depth greater than [>]3 millimeter [mm]) or who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
4. Participant who has had oral surgery or tooth extraction within 6 weeks of the screening visit.
5. Participant who has dental conditions or disease under active dental treatment or requiring immediate treatment.
6. Participant with tongue or lip piercing.
7. Participant with Oral Soft Tissue (OST) examination findings at Screening which, in the opinion of the investigator, could interfere with the conduct of the study (for example, stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling).
8. Participant who does not practice daily oral care.
Participant with oral malodor which, in the opinion of the investigator, is not expected to respond to treatment with an over-the-counter dentifrice.
Participant who, in the opinion of the investigator, should not participate in the study.

Sites / Locations

Salus Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Dentifrice

Reference Dentifrice

Arm Description

Participants will be instructed to brush twice daily (for 1 minute, morning and evening) with the experimental dentifrice (0.454% Stannous Fluoride with 0.3% Zinc Chloride) for 3 weeks.

Participants will be instructed to brush twice daily (for 1 minute, morning and evening) with the reference dentifrice (Regular Fluoride Dentifrice) for 3 weeks.

Outcomes

Primary Outcome Measures

Change in Mean Organoleptic Score from Baseline (Day 0, Pre-Brushing) to 3 Weeks (Pre-Brushing)

An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline will be calculated as mean score at 3 weeks (pre-brushing) minus mean score at Baseline (Day 0, pre-brushing).

Secondary Outcome Measures

Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (Pre-Brushing) in Mean Total Volatile Sulfur Compounds (VSCs) Concentration in Breath

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in parts per billion [ppb]) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean value at 3 weeks (pre-brushing) minus mean value at Baseline (Day 0, pre-brushing).

Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (Pre-Brushing) in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean value at 3 weeks (pre-brushing) minus mean value at Baseline (Day 0, pre-brushing).

Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (1 hour Post-Brushing) in Mean total VSC Concentration in Breath

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean value at 3 weeks (1 hour post-brushing) minus mean value at Baseline (Day 0, pre-brushing).

Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (1 hour Post-Brushing) in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean value at 3 weeks (1 hour post-brushing) minus mean value at Baseline (Day 0, pre-brushing).

Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (1 hour Post-Brushing) in Mean Breath Organoleptic Scores

An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline will be calculated as mean score at 3 weeks (1 Hour Post-Brushing) minus mean score at Baseline (Day 0, pre-brushing).

Change from Baseline (Day 0, Pre-Brushing) to 1 Hour Post-Brushing in Mean Total VSC Concentration in Breath

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Day 0.

Change from Baseline (Day 0, Pre-Brushing) to 1 Hour Post-Brushing in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Day 0.

Change from Baseline (Day 0, Pre-Brushing) to 1 Hour Post-Brushing in Mean Breath Organoleptic Scores

An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Day 0.

Change from Baseline (3 Weeks, Pre-Brushing) to 1 Hour Post-Brushing in Mean Total VSC Concentration in Breath

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Week 3.

Change from Baseline (3 Weeks, Pre-Brushing) to 1 Hour Post-Brushing in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Week 3.

Change from Baseline (3 Weeks, Pre-Brushing) to 1 Hour Post-Brushing in Mean Breath Organoleptic Scores

An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Week 3.

Full Information

NCT ID

NCT05524948

First Posted

August 30, 2022

Last Updated

January 13, 2023

Sponsor

HALEON

1. Study Identification

Unique Protocol Identification Number

NCT05524948

Brief Title

A Clinical Study to Examine the Effects of an Experimental Toothpaste Compared to a Regular Fluoride Toothpaste on Breath Odor in a Population With Gingivitis

Official Title

A Randomized, Single-Blind Clinical Study Assessing the Effects of an Experimental Dentifrice Compared to a Regular Fluoride Dentifrice on Breath Odor When Used Twice Daily for 3 Weeks in a Population With Clinically Diagnosed Gingivitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

September 26, 2022 (Actual)

Primary Completion Date

October 27, 2022 (Actual)

Study Completion Date

October 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HALEON

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to investigate the efficacy of an experimental dentifrice, containing 0.454 percent (%) stannous fluoride and 0.3% zinc chloride, to reduce oral malodor, compared to a marketed regular fluoride dentifrice after 3 weeks twice daily brushing in a population of clinically diagnosed gingivitis.

Detailed Description

This will be a single center, single blind (to the examiners undertaking the oral malodor assessments), randomized (stratified by the participant's sex), controlled, two arm parallel study in volunteers with clinically diagnosed gingivitis and oral malodor. The study will evaluate the clinical efficacy of an experimental dentifrice containing 0.454% stannous fluoride and 0.3% zinc chloride to reduce oral malodor after 3 weeks of twice-daily use compared to a regular reference dentifrice. Sufficient participants will be screened to randomize approximately 106 participants to study treatment (approximately 53 per treatment group) to ensure approximately 100 evaluable participants complete the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Halitosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Dentifrice

Arm Type

Experimental

Arm Description

Participants will be instructed to brush twice daily (for 1 minute, morning and evening) with the experimental dentifrice (0.454% Stannous Fluoride with 0.3% Zinc Chloride) for 3 weeks.

Arm Title

Reference Dentifrice

Arm Type

Active Comparator

Arm Description

Participants will be instructed to brush twice daily (for 1 minute, morning and evening) with the reference dentifrice (Regular Fluoride Dentifrice) for 3 weeks.

Intervention Type

Other

Intervention Name(s)

Experimental Dentifrice

Intervention Description

Dentifrice containing 0.454% stannous fluoride with 0.3% zinc chloride.

Intervention Type

Other

Intervention Name(s)

Reference Dentifrice

Intervention Description

Standard fluoride dentifrice containing 0.243% sodium fluoride.

Primary Outcome Measure Information:

Title

Change in Mean Organoleptic Score from Baseline (Day 0, Pre-Brushing) to 3 Weeks (Pre-Brushing)

Description

Time Frame

Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)

Secondary Outcome Measure Information:

Title

Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (Pre-Brushing) in Mean Total Volatile Sulfur Compounds (VSCs) Concentration in Breath

Description

Time Frame

Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)

Title

Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (Pre-Brushing) in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

Description

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean value at 3 weeks (pre-brushing) minus mean value at Baseline (Day 0, pre-brushing).

Time Frame

Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)

Title

Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (1 hour Post-Brushing) in Mean total VSC Concentration in Breath

Description

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean value at 3 weeks (1 hour post-brushing) minus mean value at Baseline (Day 0, pre-brushing).

Time Frame

Baseline (Day 0, Pre-Brushing) and Week 3 (1 hour Post-Brushing)

Title

Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (1 hour Post-Brushing) in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

Description

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean value at 3 weeks (1 hour post-brushing) minus mean value at Baseline (Day 0, pre-brushing).

Time Frame

Baseline (Day 0, Pre-Brushing) and Week 3 (1 hour Post-Brushing)

Title

Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (1 hour Post-Brushing) in Mean Breath Organoleptic Scores

Description

An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline will be calculated as mean score at 3 weeks (1 Hour Post-Brushing) minus mean score at Baseline (Day 0, pre-brushing).

Time Frame

Baseline (Day 0, Pre-Brushing) and Week 3 (1 hour Post-Brushing)

Title

Change from Baseline (Day 0, Pre-Brushing) to 1 Hour Post-Brushing in Mean Total VSC Concentration in Breath

Description

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Day 0.

Time Frame

Baseline (Day 0, Pre-Brushing) and Hour 1 (Post-Brushing)

Title

Change from Baseline (Day 0, Pre-Brushing) to 1 Hour Post-Brushing in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

Description

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Day 0.

Time Frame

Baseline (Day 0, Pre-Brushing) and Hour 1 (Post-Brushing)

Title

Change from Baseline (Day 0, Pre-Brushing) to 1 Hour Post-Brushing in Mean Breath Organoleptic Scores

Description

An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Day 0.

Time Frame

Baseline (Day 0, Pre-Brushing) and Hour 1 (Post-Brushing)

Title

Change from Baseline (3 Weeks, Pre-Brushing) to 1 Hour Post-Brushing in Mean Total VSC Concentration in Breath

Description

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Week 3.

Time Frame

Baseline (3 Weeks, Pre-Brushing) and Hour 1 (Post-Brushing)

Title

Change from Baseline (3 Weeks, Pre-Brushing) to 1 Hour Post-Brushing in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

Description

The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Week 3.

Time Frame

Baseline (3 Weeks, Pre-Brushing) and Hour 1 (Post-Brushing)

Title

Change from Baseline (3 Weeks, Pre-Brushing) to 1 Hour Post-Brushing in Mean Breath Organoleptic Scores

Description

An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Week 3.

Time Frame

Baseline (3 Weeks, Pre-Brushing) and Hour 1 (Post-Brushing)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. Participant who is willing and able to comply with scheduled visits, product usage requirements, study procedures and lifestyle restrictions. Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history (for example, a medical condition or medication confirmed to contribute to xerostomia),or upon oral examination, that would impact the participant's safety, wellbeing or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements. Participant with generally good oral health that fulfil all of the following: Having at least 20 natural (vital) teeth. Good oral health without lesions in the oral cavity (including the tongue) that could interfere with the study evaluations. Having clinically diagnosed, plaque-induced gingivitis defined as having 10-30% bleeding sites from the bleeding on probing assessment. At Screening (Visit 1) and prior to brushing with assigned dentifrice at Baseline (Visit 2) participants must provide 2 samples of mouth air, which must have a mean hydrogen sulfide concentration greater than 150ppb. There must be less than or equal to (<=)500ppb difference between the values measured at screening and baseline (pre-brushing). At Baseline (Visit 2), prior to brushing with assigned dentifrice participants must provide a breath sample with a mean organoleptic score greater than or equal to (>=)2. Exclusion Criteria: Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family. Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of study entry and/or during study participation or who has previously been enrolled in this study. Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. A Participant who is pregnant (self-reported) or intending to become pregnant during the study. Participant who is breastfeeding. Participant who habitually smokes, uses tobacco products or who vapes. Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds). Participant who is unwilling or, in the opinion of the investigator or medically qualified designee, unable to comply with the requirements and/or Lifestyle Considerations of the study. Participant with a recent history (within the last year) of alcohol or other substance abuse. General medical exclusions: Participant with a medical history that may prevent the Participant from participating in the study until study conclusion. Participant with, or having recent history of, bronchitis, tonsillitis or sinusitis (within 6 weeks) or any other systemic condition that can cause oral malodor for example, xerostomia, chronic acid reflux, Type 1 diabetes, Crohn's disease, celiac disease or liver/kidney conditions. Participant with a significant infectious disease, such as hepatitis, COVID-19, flu, respiratory infection, tuberculosis, or any other condition which can be transmitted in saliva or salivary aerosols which, in the opinion of the examiner, could endanger the organoleptic assessors. Participant with any condition that impacts gum health (for example, Type 2 Diabetes). General medication exclusions: Participant using any antibiotic medication within 14 days prior to screening or at any time during the study. Participant using chlorhexidine, cetylpyridinium chloride (CPC) or stannous fluoride containing mouthwash or dentifrice within 14 days prior to Visit 2 or between Visit 2 and 3. Participant taking medications which may impact oral mouth odor (for example, Diazepam, Alprazolam, Lorazepam and so on). General oral exclusions: Participant with orthodontic or prosthetic appliances (fixed or removable), including dental implants. Participant having had professional dental cleaning (oral prophylaxis) within 3 months prior to the screening visit or at any time during the study. Participant with signs of active periodontal disease (with probing depth greater than [>]3 millimeter [mm]) or who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening. Participant who has had oral surgery or tooth extraction within 6 weeks of the screening visit. Participant who has dental conditions or disease under active dental treatment or requiring immediate treatment. Participant with tongue or lip piercing. Participant with Oral Soft Tissue (OST) examination findings at Screening which, in the opinion of the investigator, could interfere with the conduct of the study (for example, stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling). Participant who does not practice daily oral care. Participant with oral malodor which, in the opinion of the investigator, is not expected to respond to treatment with an over-the-counter dentifrice. Participant who, in the opinion of the investigator, should not participate in the study.

Facility Information:

Facility Name

Salus Research Inc.

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46825

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Learn more about this trial

A Clinical Study to Examine the Effects of an Experimental Toothpaste Compared to a Regular Fluoride Toothpaste on Breath Odor in a Population With Gingivitis

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