HealthyPhase 4NCT05645705
A Two-Week Study of Clinical Safety and Saliva Flow Quantification
A Phase 4 study testing Colgate Cavity Protection Toothpaste, LISTERINE Cool Mint Antiseptic Mouthwash and Listerine Advanced Gum Alcohol in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
The purpose of this study is to assess the oral tissue tolerance (tissues within the mouth) for irritation caused by added ingredients in mouthwashes. This will be assessed based on oral tissue exams and adverse reactions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Colgate Cavity Protection Toothpaste, LISTERINE Cool Mint Antiseptic Mouthwash and Listerine Advanced Gum Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2022to 16 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
- Evidence of a personally signed and dated informed consent document indicating the participant (or legally acceptable representative) has been informed of all pertinent aspects of the trial
- Able to read and understand the local language (participant is capable of reading the documents)
- Adequate oral hygiene (that is, brush teeth daily and exhibit no signs of oral neglect)
- Adults, 18 years of age and older, in good general and oral health without any known allergy to commercial dental products or cosmetics
- Evidence of being fully vaccinated for corona virus disease-2019 (COVID-19) (adults 60 years and older)
Show all 13Show fewer
- Negative pregnancy urine tests (females of child-bearing potential only)
- Females of childbearing potential must be using a medically acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
- Resting baseline unstimulated salivary sample must be equal to or greater than 0.3 milliliter per minute (mL/min) to continue in the study
- A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
- Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator
- Absence of advanced periodontitis based on a clinical examination and discretion of the dental examiner
- Absence of fixed or removable orthodontic appliance or removable partial dentures
Who cannot join
- History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouthwashes and red food dye
- Dental prophylaxis within four weeks prior to Baseline visit
- History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, cyclosporin A, immunostimulants/ immunomodulators during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication (ibuprofen, Aspirin); oral steroids and calcium channel blockers are acceptable at the discretion of the investigator
- Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, sodium fluoride with CPC, stannous fluoride, zinc or chlorhexidine digluconate containing mouthwashes and toothpastes within the four weeks prior to the Baseline exam
- Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products)
Show all 18Show fewer
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results)
- Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e-cigarette usage
- Males with a pregnant partner or a partner who is currently trying to become pregnant
- Suspected alcohol or substance abuse (examples, amphetamines, benzodiazepines, cocaine, marijuana, opiates)
- Significant medical or oral condition which may interfere with a participant's participation in the study, including cancer, chronic kidney disease, chronic obstructive pulmonary disease (COPD), immunocompromised state (weakened immune system) from solid organ transplant, serious heart conditions, (such as heart failure, coronary artery disease, or cardiomyopathies) Sickle cell disease, Type 2 diabetes mellitus at the discretion of the Investigator
- Participation in any clinical trial within 30 days of Screening visit
- Diagnosed Temporo-mandibular joint dysfunction/disorder
- Participants who wear bruxing devices, dental aligners, retainers
- Participants who were previously screened and ineligible or were randomized to receive investigational product
- Participants who are related to those persons involved directly or indirectly with the conduct of this study (that is, principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each)
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the participant inappropriate for entry into this study
- COVID-19 restrictions: participants who fail to meet the criteria of the site's screening consent for Preventing Infection in the site's COVID-19 consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-Week Clinical Safety and Saliva Flow Quantification
The purpose of this study is to assess the oral tissue tolerance (tissues within the mouth) for irritation caused by added ingredients in mouthwashes. This will be assessed based on oral tissue exams and adverse reactions.
- Conditions
- Healthy
- Being tested
- Colgate Cavity Protection Toothpaste, LISTERINE Cool Mint Antiseptic Mouthwash, Listerine Advanced Gum Alcohol, Listerine Advanced Gum Zero, LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colgate Cavity Protection ToothpasteOther
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
LISTERINE Cool Mint Antiseptic MouthwashOther
Participants will use 20 mL of LISTERINE Cool Mint Antiseptic Mouthwash for 30 seconds after brushing twice daily.
Listerine Advanced Gum AlcoholOther
Participants will use 20 mL of Listerine Advanced Gum Alcohol Rinse for 30 seconds after brushing twice daily.
Listerine Advanced Gum ZeroOther
Participants will use 20 mL of Listerine Advanced Gum Zero Rinse for 30 seconds after brushing twice daily.
LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool MintOther
Participants will use 20 mL of LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint Rinse for 30 seconds after brushing twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Brush/ LISTERINE Cool Mint Antiseptic Mouthwash | Experimental | At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. Receives: Other: Colgate Cavity Protection Toothpaste; Other: LISTERINE Cool Mint Antiseptic Mouthwash |
| Arm 2: Brush / Listerine Advanced Gum Alcohol | Experimental | At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. Receives: Other: Colgate Cavity Protection Toothpaste; Other: Listerine Advanced Gum Alcohol |
| Arm 3: Brush / Listerine Advanced Gum Zero | Experimental | At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. Receives: Other: Colgate Cavity Protection Toothpaste; Other: Listerine Advanced Gum Zero |
| Arm 4: Brush / LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint | Experimental | At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. Receives: Other: Colgate Cavity Protection Toothpaste; Other: LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint |
| Arm 5: Brush Only | Other | At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. Receives: Other: Colgate Cavity Protection Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Oral Tolerance Based on Oral Hard and Soft Tissue Exams
Change from baseline in oral tolerance based on oral had and soft tissue exams will be reported. Oral examination will be conducted to monitor oral soft and hard tissues tolerance to the treatments. Buccal and sublingual mucosae, lips/labial mucosa, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations will be examined and findings will be recorded in the electronic data capture (EDC) system.
Measured: Baseline up to Day 14
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participant's participation in the trial.
Measured: Up to Day 14
Secondary outcomes (2)
Salivary Flow Rate
Saliva samples will be collected by participants at baseline and then immediately (0), 2, 5, 10, 15 and 30 minute timepoints after intervention. The final amount of saliva will be weighed to calculate the milliliter per minute (mL/min). The saliva flow rate will be expressed as mL/min.
Measured: Baseline and immediately (0), 2, 5, 10, 15 and 30 minutes after intervention use
Saliva Potential of Hydrogen (pH)
The pH value of saliva will be measured by placing the saliva sample onto the pH-sensitive electrode.
Measured: Baseline and 2, 5, 10, 15 and 30 minutes after intervention use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start28 Nov 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Milleman, DDS, Principal investigator, Salus Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645705
- Sponsor's protocol ID
- CCSORC005121
- Other IDs
- CCSORC005121
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Publications
Milleman K, Bosma ML, Saito A, Gorecki P, Ding Y, DelSasso A, Wills K, Milleman JL. Comparison of safety, salivary flow rate, and pH with different mouthrinse formulations in addition to toothbrushing vs toothbrushing only: Results from a 2-week phase 4 randomized controlled clinical trial. J Am Dent Assoc. 2025 Dec;156(12):991-1000.e3. doi: 10.1016/j.adaj.2025.08.022.
PubMed 41338687
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Week Clinical Safety and Saliva Flow Quantification
- ClinicalTrials.gov ID
- NCT05645705
- Acronym / sponsor ID
- CCSORC005121
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
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 assess the oral tissue tolerance (tissues within the mouth) for irritation caused by added ingredients in mouthwashes. This will be assessed based on oral tissue exams and adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Brush/ LISTERINE Cool Mint Antiseptic Mouthwash | Experimental | Other: Colgate Cavity Protection Toothpaste, Other: LISTERINE Cool Mint Antiseptic MouthwashAt Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. |
| Arm 2: Brush / Listerine Advanced Gum Alcohol | Experimental | Other: Colgate Cavity Protection Toothpaste, Other: Listerine Advanced Gum AlcoholAt Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. |
| Arm 3: Brush / Listerine Advanced Gum Zero | Experimental | Other: Colgate Cavity Protection Toothpaste, Other: Listerine Advanced Gum ZeroAt Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. |
| Arm 4: Brush / LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint | Experimental | Other: Colgate Cavity Protection Toothpaste, Other: LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool MintAt Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. |
| Arm 5: Brush Only | Other | Other: Colgate Cavity Protection ToothpasteAt Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
- Evidence of a personally signed and dated informed consent document indicating the participant (or legally acceptable representative) has been informed of all pertinent aspects of the trial
- Able to read and understand the local language (participant is capable of reading the documents)
- Adequate oral hygiene (that is, brush teeth daily and exhibit no signs of oral neglect)
- Adults, 18 years of age and older, in good general and oral health without any known allergy to commercial dental products or cosmetics
Key exclusion criteria (18 listed)
- History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouthwashes and red food dye
- Dental prophylaxis within four weeks prior to Baseline visit
- History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, cyclosporin A, immunostimulants/ immunomodulators during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication (ibuprofen, Aspirin); oral steroids and calcium channel blockers are acceptable at the discretion of the investigator
- Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, sodium fluoride with CPC, stannous fluoride, zinc or chlorhexidine digluconate containing mouthwashes and toothpastes within the four weeks prior to the Baseline exam
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 |
|---|---|---|
| Colgate Cavity Protection ToothpasteParticipants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily. | Other | Arm 1: Brush/ LISTERINE Cool Mint Antiseptic Mouthwash, Arm 2: Brush / Listerine Advanced Gum Alcohol, Arm 3: Brush / Listerine Advanced Gum Zero, Arm 4: Brush / LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint, Arm 5: Brush Only |
| LISTERINE Cool Mint Antiseptic MouthwashParticipants will use 20 mL of LISTERINE Cool Mint Antiseptic Mouthwash for 30 seconds after brushing twice daily. | Other | Arm 1: Brush/ LISTERINE Cool Mint Antiseptic Mouthwash |
| Listerine Advanced Gum AlcoholParticipants will use 20 mL of Listerine Advanced Gum Alcohol Rinse for 30 seconds after brushing twice daily. | Other | Arm 2: Brush / Listerine Advanced Gum Alcohol |
| Listerine Advanced Gum ZeroParticipants will use 20 mL of Listerine Advanced Gum Zero Rinse for 30 seconds after brushing twice daily. | Other | Arm 3: Brush / Listerine Advanced Gum Zero |
| LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool MintParticipants will use 20 mL of LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint Rinse for 30 seconds after brushing twice daily. | Other | Arm 4: Brush / LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint |
Primary outcome
Change from Baseline in Oral Tolerance Based on Oral Hard and Soft Tissue Exams
Time frame: Baseline up to Day 14
Change from baseline in oral tolerance based on oral had and soft tissue exams will be reported. Oral examination will be conducted to monitor oral soft and hard tissues tolerance to the treatments. Buccal and sublingual mucosae, lips/labial mucosa, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations will be examined and findings will be recorded in the electronic data capture (EDC) system.
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 14
An AE is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participant's participation in the trial.
2 secondary outcomes
Salivary Flow Rate
Time frame: Baseline and immediately (0), 2, 5, 10, 15 and 30 minutes after intervention use
Saliva Potential of Hydrogen (pH)
Time frame: Baseline and 2, 5, 10, 15 and 30 minutes after intervention use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 41338687Milleman K, Bosma ML, Saito A, Gorecki P, Ding Y, DelSasso A, Wills K, Milleman JL. Comparison of safety, salivary flow rate, and pH with different mouthrinse formulations in addition to toothbrushing vs toothbrushing only: Results from a 2-week phase 4 randomized controlled clinical trial. J Am Dent Assoc. 2025 Dec;156(12):991-1000.e3. doi: 10.1016/j.adaj.2025.08.022.
- Two-Week Clinical Safety and Saliva Flow QuantificationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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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.
Jeffery Milleman, DDS principal investigator
Salus Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colgate Cavity Protection Toothpaste, LISTERINE Cool Mint Antiseptic Mouthwash and Listerine Advanced Gum Alcohol in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) 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 13 inclusion and 18 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 10 Oct 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Oral Tolerance Based on Oral Hard and Soft Tissue Exams (time frame: Baseline up to Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645705, which also lists 1 linked publication.
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 10 Oct 2023.