HalitosisNCT05524948
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
A study testing Experimental Dentifrice and Reference Dentifrice in people with Halitosis, run by HALEON at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Halitosis
- What is being tested?
- Experimental Dentifrice and Reference Dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to 27 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Halitosis
- Being tested
- Experimental Dentifrice, Reference Dentifrice
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental DentifriceOther
Dentifrice containing 0.454% stannous fluoride with 0.3% zinc chloride.
Reference DentifriceOther
Standard fluoride dentifrice containing 0.243% sodium fluoride.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Dentifrice | Experimental | 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. Receives: Other: Experimental Dentifrice |
| Reference Dentifrice | Active comparator | Participants will be instructed to brush twice daily (for 1 minute, morning and evening) with the reference dentifrice (Regular Fluoride Dentifrice) for 3 weeks. Receives: Other: Reference Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores
An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored 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 was calculated as score at Week 3 (Pre-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). Analysis was performed using Analysis of Covariance (ANCOVA) method.
Measured: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
Secondary outcomes (11)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Total Volatile Sulfur Compounds (VSCs) Concentration in Breath
The VSCs concentration in breath sample was evaluated using OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (in parts per billion [ppb]) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (Pre-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Measured: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (Pre-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Measured: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Measured: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Measured: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores
An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored 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 was calculated as score at Week 3 (1 Hour Post-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Measured: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Total VSC Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Day 0 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Measured: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Day 0 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Measured: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Breath Organoleptic Scores
An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored 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 was calculated as score at Day 0 (1 Hour Post-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Measured: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing).
Measured: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing).
Measured: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores
An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored 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 was calculated as score at Week 3 (1 Hour Post-Brushing) minus score at (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing).
Measured: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start26 Sep 2022
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HalitosisStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524948
- Sponsor's protocol ID
- 300025
- Status last verified
- Mar 2024
- First submitted
- 30 Aug 2022
- Last updated
- 26 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05524948
- Acronym / sponsor ID
- 300025
- Conditions
- Halitosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Dentifrice | Experimental | Other: Experimental DentifriceParticipants 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. |
| Reference Dentifrice | Active comparator | Other: Reference DentifriceParticipants will be instructed to brush twice daily (for 1 minute, morning and evening) with the reference dentifrice (Regular Fluoride Dentifrice) for 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental DentifriceDentifrice containing 0.454% stannous fluoride with 0.3% zinc chloride. | Other | Experimental Dentifrice |
| Reference DentifriceStandard fluoride dentifrice containing 0.243% sodium fluoride. | Other | Reference Dentifrice |
Primary outcome
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored 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 was calculated as score at Week 3 (Pre-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). Analysis was performed using Analysis of Covariance (ANCOVA) method.
11 secondary outcomes
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Total Volatile Sulfur Compounds (VSCs) Concentration in Breath
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Total VSC Concentration in Breath
Time frame: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
Time frame: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Breath Organoleptic Scores
Time frame: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath
Time frame: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
Time frame: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores
Time frame: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
Related trials for Halitosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment.
Periodontal Diseases, Oral Halitosis
Active, not recruiting
Effects of Green Tea Mouthwash on Halitosis, Periodontal Health, and Stress in Orthodontic Patients
Halitosis, Periodontal Health
RecruitingPhase 2
Effectiveness of Aquamin® in Mitigating Halitosis
Healthy, Halitosis
Not yet recruiting
Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults
Oral Malodor (Halitosis), Oral Dryness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Dentifrice and Reference Dentifrice in people with Halitosis, run by HALEON at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores (time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.