HealthyPhase 4NCT06010758
A Two-Week Study of an Anticavity Low pH Mouthwash
A Phase 4 study testing Listerine Experimental Mouthwash, Colgate Cavity Protection Toothpaste and Listerine Total Care Zero in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
The purpose of this clinical trial is to evaluate the oral tolerance of a new, experimental mouthwash compared to two mouth rinse formulations, which are already marketed, as well as compared to a tooth brushing only control group. 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?
- Listerine Experimental Mouthwash, Colgate Cavity Protection Toothpaste and Listerine Total Care Zero
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 3 Aug 2023
- 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 clinical trial (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical trial) 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 Coronavirus Disease 2019 (COVID-19) (adults 60 years and older)
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- 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 clinical trial
- Resting baseline unstimulated salivary sample must be equal to or greater than 0.3 milliliters per minute (mL/min) to continue in the clinical trial
- 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 clinical trial 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 cetylpyridinium chloride (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) specifically Cinnamyl Alcohol, Benzyl Alcohol, Citral, Citronellol, Linalool, and Limonene
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of clinical trial results)
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- 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 (for example, amphetamines, benzodiazepines, cocaine, marijuana, opiates)
- Significant medical or oral condition which may interfere with a participant's participation in the clinical trial, 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 clinical trial (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 clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial to Investigate Two-Week Clinical Safety, Changes in Salivary Flow and pH Following Use of an Anticavity Low pH Mouthwash
The purpose of this clinical trial is to evaluate the oral tolerance of a new, experimental mouthwash compared to two mouth rinse formulations, which are already marketed, as well as compared to a tooth brushing only control group.
- Conditions
- Healthy
- Being tested
- Listerine Experimental Mouthwash, Colgate Cavity Protection Toothpaste, Listerine Total Care Zero, Listerine Cool Mint Zero
- Keywords
- Mouth wash, Mouth rinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listerine Experimental MouthwashDrug
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day, morning and night.
Colgate Cavity Protection ToothpasteDrug
Participants will brush twice daily for 1 timed minute with Colgate Cavity Protection toothpaste.
Listerine Total Care ZeroDrug
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash twice a day, morning and night.
Listerine Cool Mint ZeroOther
After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash twice a day, morning and night.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Brush / Listerine Experimental Mouthwash | Experimental | After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day. Receives: Drug: Listerine Experimental Mouthwash; Drug: Colgate Cavity Protection Toothpaste |
| Arm 2: Brush / Listerine Cool Mint Zero | Experimental | After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with experimental mouthwash twice a day. Receives: Drug: Colgate Cavity Protection Toothpaste; Other: Listerine Cool Mint Zero |
| Arm 3: Brush / Listerine Total Care Zero | Experimental | After brushing for 1 timed minute, participants will rinse full strength for 1 minute with experimental mouthwash twice a day. Receives: Drug: Colgate Cavity Protection Toothpaste; Drug: Listerine Total Care Zero |
| Arm 4: Brush only | Other | Participants will brush their teeth using a soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily for 1 timed minute and then rinse with water for 1 minute. Receives: Drug: Colgate Cavity Protection Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues
Oral tissue tolerance will include the assessment of the number of participants with treatment-emergent adverse events (TEAEs) and those experiencing investigational product-related AEs throughout the observational study period of 14 days. In particular, oral examinations will include clinical evaluation of soft and hard tissues, such as buccal and sublingual mucosa, tongue, hard and soft palate, gingiva, uvula, oropharynx, teeth, and dental restorations, with findings recorded in the electronic data capture (EDC) system.
Measured: 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 specified timepoints. The final amount of saliva will be weighed and flow rate will be determined.
Measured: Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints
Saliva Potential of Hydrogen (pH)
The pH value of saliva will be measured by placing the saliva sample onto the pH-sensitive electrode.
Measured: Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start17 Jul 2023
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 163 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
- NCT06010758
- Sponsor's protocol ID
- CCSORC005342
- Other IDs
- CCSORC005342
- Status last verified
- Dec 2023
- First submitted
- 18 Jul 2023
- Last updated
- 12 Jan 2024
- 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
Lynch MC, Cortelli SC, McGuire JA, Zhang J, Ricci-Nittel D, Mordas CJ, Aquino DR, Cortelli JR. The effects of essential oil mouthrinses with or without alcohol on plaque and gingivitis: a randomized controlled clinical study. BMC Oral Health. 2018 Jan 10;18(1):6. doi: 10.1186/s12903-017-0454-6.
PubMed 29321067Cortelli SC, Cortelli JR, Shang H, McGuire JA, Charles CA. Long-term management of plaque and gingivitis using an alcohol-free essential oil containing mouthrinse: a 6-month randomized clinical trial. Am J Dent. 2013 Jun;26(3):149-55.
PubMed 23986962
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Investigate Two-Week Clinical Safety, Changes in Salivary Flow and pH Following Use of an Anticavity Low pH Mouthwash
- ClinicalTrials.gov ID
- NCT06010758
- Acronym / sponsor ID
- CCSORC005342
- Conditions
- Healthy
- Keywords
- Mouth wash, Mouth rinse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 25 Aug 2023 (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 clinical trial is to evaluate the oral tolerance of a new, experimental mouthwash compared to two mouth rinse formulations, which are already marketed, as well as compared to a tooth brushing only control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Brush / Listerine Experimental Mouthwash | Experimental | Drug: Listerine Experimental Mouthwash, Drug: Colgate Cavity Protection ToothpasteAfter brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day. |
| Arm 2: Brush / Listerine Cool Mint Zero | Experimental | Drug: Colgate Cavity Protection Toothpaste, Other: Listerine Cool Mint ZeroAfter brushing for 1 timed minute, participants will rinse full strength for 30 seconds with experimental mouthwash twice a day. |
| Arm 3: Brush / Listerine Total Care Zero | Experimental | Drug: Colgate Cavity Protection Toothpaste, Drug: Listerine Total Care ZeroAfter brushing for 1 timed minute, participants will rinse full strength for 1 minute with experimental mouthwash twice a day. |
| Arm 4: Brush only | Other | Drug: Colgate Cavity Protection ToothpasteParticipants will brush their teeth using a soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily for 1 timed minute and then rinse with water for 1 minute. |
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 clinical trial (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical trial) 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 (16 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 clinical trial 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 cetylpyridinium chloride (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) specifically Cinnamyl Alcohol, Benzyl Alcohol, Citral, Citronellol, Linalool, and Limonene
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 |
|---|---|---|
| Listerine Experimental MouthwashAfter brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day, morning and night. | Drug | Arm 1: Brush / Listerine Experimental Mouthwash |
| Colgate Cavity Protection ToothpasteParticipants will brush twice daily for 1 timed minute with Colgate Cavity Protection toothpaste. | Drug | Arm 1: Brush / Listerine Experimental Mouthwash, Arm 2: Brush / Listerine Cool Mint Zero, Arm 3: Brush / Listerine Total Care Zero, Arm 4: Brush only |
| Listerine Total Care ZeroAfter brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash twice a day, morning and night. | Drug | Arm 3: Brush / Listerine Total Care Zero |
| Listerine Cool Mint ZeroAfter brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash twice a day, morning and night. | Other | Arm 2: Brush / Listerine Cool Mint Zero |
Primary outcome
Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues
Time frame: Up to Day 14
Oral tissue tolerance will include the assessment of the number of participants with treatment-emergent adverse events (TEAEs) and those experiencing investigational product-related AEs throughout the observational study period of 14 days. In particular, oral examinations will include clinical evaluation of soft and hard tissues, such as buccal and sublingual mucosa, tongue, hard and soft palate, gingiva, uvula, oropharynx, teeth, and dental restorations, with findings 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: Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints
Saliva Potential of Hydrogen (pH)
Time frame: Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints
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 12 Jan 2024.
- Background: PubMed 29321067Lynch MC, Cortelli SC, McGuire JA, Zhang J, Ricci-Nittel D, Mordas CJ, Aquino DR, Cortelli JR. The effects of essential oil mouthrinses with or without alcohol on plaque and gingivitis: a randomized controlled clinical study. BMC Oral Health. 2018 Jan 10;18(1):6. doi: 10.1186/s12903-017-0454-6.
- Background: PubMed 23986962Cortelli SC, Cortelli JR, Shang H, McGuire JA, Charles CA. Long-term management of plaque and gingivitis using an alcohol-free essential oil containing mouthrinse: a 6-month randomized clinical trial. Am J Dent. 2013 Jun;26(3):149-55.
- A Randomized Clinical Trial to Investigate Two-Week Clinical Safety, Changes in Salivary Flow and pH Following Use of an Anticavity Low pH MouthwashLink 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 Listerine Experimental Mouthwash, Colgate Cavity Protection Toothpaste and Listerine Total Care Zero 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 16 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 12 Jan 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.
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?
Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues (time frame: 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 NCT06010758, which also lists 2 linked publications.
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 12 Jan 2024.