xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06010758</url>
    </required_header>
    <id_info>
      <org_study_id>CCSORC005342</org_study_id>
      <secondary_id>CCSORC005342</secondary_id>
      <nct_id>NCT06010758</nct_id>
    </id_info>
    <brief_title>A Two-Week Study of an Anticavity Low pH Mouthwash</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johnson &amp; Johnson Consumer Inc. (J&amp;JCI)</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Johnson &amp; Johnson Consumer and Personal Products Worldwide</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this clinical trial is to evaluate the oral tolerance of a new, experimental&#xD;
        mouthwash compared to two mouth rinse formulations, which are already marketed, as well as&#xD;
        compared to a tooth brushing only control group.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Actual">August 3, 2023</completion_date>
    <primary_completion_date type="Actual">August 3, 2023</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues</measure>
      <time_frame>Up to Day 14</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Up to Day 14</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Salivary Flow Rate</measure>
      <time_frame>Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints</time_frame>
      <description>Saliva samples will be collected by participants at specified timepoints. The final amount of saliva will be weighed and flow rate will be determined.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Saliva Potential of Hydrogen (pH)</measure>
      <time_frame>Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints</time_frame>
      <description>The pH value of saliva will be measured by placing the saliva sample onto the pH-sensitive electrode.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">163</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Arm 1: Brush / Listerine Experimental Mouthwash</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2: Brush / Listerine Cool Mint Zero</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with experimental mouthwash twice a day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 3: Brush / Listerine Total Care Zero</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After brushing for 1 timed minute, participants will rinse full strength for 1 minute with experimental mouthwash twice a day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 4: Brush only</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Listerine Experimental Mouthwash</intervention_name>
      <description>After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day, morning and night.</description>
      <arm_group_label>Arm 1: Brush / Listerine Experimental Mouthwash</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Colgate Cavity Protection Toothpaste</intervention_name>
      <description>Participants will brush twice daily for 1 timed minute with Colgate Cavity Protection toothpaste.</description>
      <arm_group_label>Arm 1: Brush / Listerine Experimental Mouthwash</arm_group_label>
      <arm_group_label>Arm 2: Brush / Listerine Cool Mint Zero</arm_group_label>
      <arm_group_label>Arm 3: Brush / Listerine Total Care Zero</arm_group_label>
      <arm_group_label>Arm 4: Brush only</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Listerine Total Care Zero</intervention_name>
      <description>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.</description>
      <arm_group_label>Arm 3: Brush / Listerine Total Care Zero</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Listerine Cool Mint Zero</intervention_name>
      <description>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.</description>
      <arm_group_label>Arm 2: Brush / Listerine Cool Mint Zero</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Able to comprehend and follow the requirements and restrictions of the clinical trial&#xD;
               (including willingness to use the assigned study products per instructions,&#xD;
               availability on scheduled visit dates and likeliness of completing the clinical trial)&#xD;
               based upon research site personnel's assessment&#xD;
  &#xD;
            -  Evidence of a personally signed and dated informed consent document indicating the&#xD;
               participant (or legally acceptable representative) has been informed of all pertinent&#xD;
               aspects of the trial&#xD;
  &#xD;
            -  Able to read and understand the local language (participant is capable of reading the&#xD;
               documents)&#xD;
  &#xD;
            -  Adequate oral hygiene (that is, brush teeth daily and exhibit no signs of oral&#xD;
               neglect)&#xD;
  &#xD;
            -  Adults, 18 years of age and older, in good general and oral health without any known&#xD;
               allergy to commercial dental products or cosmetics&#xD;
  &#xD;
            -  Evidence of being fully vaccinated for Coronavirus Disease 2019 (COVID-19) (adults 60&#xD;
               years and older)&#xD;
  &#xD;
            -  Negative pregnancy urine tests (females of child-bearing potential only)&#xD;
  &#xD;
            -  Females of childbearing potential must be using a medically acceptable method of birth&#xD;
               control for at least one month prior to Visit 1 and agree to continue using this&#xD;
               method during their participation in the clinical trial&#xD;
  &#xD;
            -  Resting baseline unstimulated salivary sample must be equal to or greater than 0.3&#xD;
               milliliters per minute (mL/min) to continue in the clinical trial&#xD;
  &#xD;
            -  A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that&#xD;
               are grossly carious, extensively restored, orthodontically banded, abutments,&#xD;
               exhibiting severe generalized cervical and/or enamel abrasion, or third molars will&#xD;
               not be included in the tooth count&#xD;
  &#xD;
            -  Absence of significant oral soft tissue pathology, excluding plaque-induced&#xD;
               gingivitis, based on a visual examination and at the discretion of the Investigator&#xD;
  &#xD;
            -  Absence of advanced periodontitis based on a clinical examination and discretion of&#xD;
               the dental examiner&#xD;
  &#xD;
            -  Absence of fixed or removable orthodontic appliance or removable partial dentures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of significant adverse effects, including sensitivities or suspected&#xD;
               allergies, following use of oral hygiene products such as toothpastes, mouthwashes,&#xD;
               and red food dye&#xD;
  &#xD;
            -  Dental prophylaxis within four weeks prior to Baseline visit&#xD;
  &#xD;
            -  History of medical conditions requiring prophylactic antibiotic coverage prior to&#xD;
               invasive dental procedures; Use of antibiotics, anti-inflammatory or anticoagulant&#xD;
               therapy, phenytoin sodium or diphenylhydantoin, cyclosporin A, immunostimulants/&#xD;
               immunomodulators during the clinical trial or within the one month prior to the&#xD;
               Baseline exam. Intermittent use of certain anti-inflammatory medication (ibuprofen,&#xD;
               Aspirin); oral steroids and calcium channel blockers are acceptable at the discretion&#xD;
               of the investigator&#xD;
  &#xD;
            -  Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan,&#xD;
               essential oils, cetylpyridinium chloride, sodium fluoride with cetylpyridinium&#xD;
               chloride (CPC), stannous fluoride, zinc or chlorhexidine digluconate containing&#xD;
               mouthwashes and toothpastes within the four weeks prior to the Baseline exam&#xD;
  &#xD;
            -  Known allergy or sensitivity or history of significant adverse effects to any of the&#xD;
               investigational product and/or product ingredients (or other ingredients in the&#xD;
               products) specifically Cinnamyl Alcohol, Benzyl Alcohol, Citral, Citronellol,&#xD;
               Linalool, and Limonene&#xD;
  &#xD;
            -  Self-reported pregnancy or lactation (this criterion is due to oral tissue changes&#xD;
               related to pregnancy and nursing which can affect interpretation of clinical trial&#xD;
               results)&#xD;
  &#xD;
            -  Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping, and&#xD;
               e-cigarette usage&#xD;
  &#xD;
            -  Males with a pregnant partner or a partner who is currently trying to become pregnant&#xD;
  &#xD;
            -  Suspected alcohol or substance abuse (for example, amphetamines, benzodiazepines,&#xD;
               cocaine, marijuana, opiates)&#xD;
  &#xD;
            -  Significant medical or oral condition which may interfere with a participant's&#xD;
               participation in the clinical trial, including cancer, chronic kidney disease, chronic&#xD;
               obstructive pulmonary disease (COPD), immunocompromised state (weakened immune system)&#xD;
               from solid organ transplant, serious heart conditions, (such as heart failure,&#xD;
               coronary artery disease, or cardiomyopathies) Sickle cell disease, Type 2 diabetes&#xD;
               mellitus at the discretion of the Investigator&#xD;
  &#xD;
            -  Participation in any clinical trial within 30 days of Screening visit&#xD;
  &#xD;
            -  Diagnosed Temporo-mandibular joint dysfunction/disorder&#xD;
  &#xD;
            -  Participants who wear bruxing devices, dental aligners, retainers&#xD;
  &#xD;
            -  Participants who were previously screened and ineligible or were randomized to receive&#xD;
               investigational product&#xD;
  &#xD;
            -  Participants who are related to those persons involved directly or indirectly with the&#xD;
               conduct of this clinical trial (that is, principal investigator, sub-investigators,&#xD;
               study coordinators, other site personnel, employees of Johnson &amp; Johnson subsidiaries,&#xD;
               contractors of Johnson &amp; Johnson, and the families of each)&#xD;
  &#xD;
            -  Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
               abnormality that may increase the risk associated with study participation or&#xD;
               investigational product administration or may interfere with the interpretation of&#xD;
               study results and, in the judgment of the Investigator, would make the participant&#xD;
               inappropriate for entry into this clinical trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jeffery Milleman, DDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Salus Research, Inc.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Salus Research, Inc.</name>
        <address>
          <city>Fort Wayne</city>
          <state>Indiana</state>
          <zip>46825</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>29321067</PMID>
    </reference>
    <reference>
      <citation>Cortelli 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.</citation>
      <PMID>23986962</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mouth wash</keyword>
    <keyword>Mouth rinse</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Listerine</mesh_term>
      <mesh_term>Sodium Fluoride</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Johnson &amp; 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.</ipd_description>
      <ipd_url>http://yoda.yale.edu.</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06010758
  org study id: CCSORC005342
  secondary id: CCSORC005342
  nct id: NCT06010758
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Investigator)
  measure: Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues
  time frame: Up to Day 14
  description: 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.
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Up to Day 14
  description: 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.
  measure: Salivary Flow Rate
  time frame: Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints
  description: Saliva samples will be collected by participants at specified timepoints. The final amount of saliva will be weighed and flow rate will be determined.
  measure: Saliva Potential of Hydrogen (pH)
  time frame: Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints
  description: The pH value of saliva will be measured by placing the saliva sample onto the pH-sensitive electrode.
  arm group label: Arm 1: Brush / Listerine Experimental Mouthwash
  arm group type: Experimental
  description: After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day.
  arm group label: Arm 2: Brush / Listerine Cool Mint Zero
  arm group type: Experimental
  description: After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with experimental mouthwash twice a day.
  arm group label: Arm 3: Brush / Listerine Total Care Zero
  arm group type: Experimental
  description: After brushing for 1 timed minute, participants will rinse full strength for 1 minute with experimental mouthwash twice a day.
  arm group label: Arm 4: Brush only
  arm group type: Other
  description: 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.
  intervention type: Drug
  intervention name: Listerine Experimental Mouthwash
  description: After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day, morning and night.
  arm group label: Arm 1: Brush / Listerine Experimental Mouthwash
  intervention type: Drug
  intervention name: Colgate Cavity Protection Toothpaste
  description: Participants will brush twice daily for 1 timed minute with Colgate Cavity Protection toothpaste.
  arm group label: Arm 1: Brush / Listerine Experimental Mouthwash
  arm group label: Arm 2: Brush / Listerine Cool Mint Zero
  arm group label: Arm 3: Brush / Listerine Total Care Zero
  arm group label: Arm 4: Brush only
  intervention type: Drug
  intervention name: Listerine Total Care Zero
  description: 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.
  arm group label: Arm 3: Brush / Listerine Total Care Zero
  intervention type: Other
  intervention name: Listerine Cool Mint Zero
  description: 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.
  arm group label: Arm 2: Brush / Listerine Cool Mint Zero
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jeffery Milleman, DDS
  role: Principal Investigator
  affiliation: Salus Research, Inc.
  facility: 
  country: United States
  citation: 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.
  PMID: 29321067
  citation: Cortelli 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.
  PMID: 23986962
  responsible party type: Sponsor
  mesh term: Listerine
  mesh term: Sodium Fluoride
  sharing ipd: Yes
  ipd description: 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.
  ipd url: http://yoda.yale.edu.