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HealthyPhase 4NCT05526586

A Twelve Week Study of Prototypes Mouth Rinses

A Phase 4 study testing Colgate Cavity Protection Toothpaste, Zero Alcohol Gum Prototype and Alcohol Gum Prototype in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of two essential oil containing experimental mouth rinse formulations and an essential oil containing mouth rinse compared to a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a… 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, Zero Alcohol Gum Prototype and Alcohol Gum Prototype
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteUnited States
Study dates
31 Aug 2022to 8 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 subject (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 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
  • A mean gingival index greater than or equal to (>=) 1.95 per the Modified Gingival Index at Baseline
  • A mean plaque index >=1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index
  • Greater than or equal to 10 percent (%) bleeding sites at Baseline
  • 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 with probing depths of 4 millimeters (mm) or less except for two sites allowed with a probing depth of 5mm at Baseline
  • 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, mouth rinses and red food dye
  • Dental prophylaxis within four weeks prior to Baseline visit
  • More than two sites that have periodontal pockets depths measuring 5mm or greater in depth
  • 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 mouth rinses and toothpastes within the four weeks prior to the Baseline exam
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  • 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)
  • Consumption of probiotic drinks/supplements within one week prior to Screening/Baseline
  • 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 (example, amphetamines, benzodiazepines, cocaine, marijuana, opiates)
  • Significant medical or oral condition which may interfere with a subject's participation in the study, including cancer, chronic kidney disease, COPD (chronic obstructive pulmonary disease), 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
  • Subjects who wear bruxing devices, dental aligners, retainers
  • Subjects who were previously screened and ineligible or were randomized to receive investigational product
  • Subjects 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 subject 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.

United States1 site

  • Salus Research, Inc.

    Fort Wayne, Indiana, 46825

Other trials in United States

About this study

Official title: Twelve Week Safety, Clinical, and Microbiological Efficacy of Experimental Zinc Containing Mouth Rinses

The purpose of this study is to evaluate the safety and efficacy of two essential oil containing experimental mouth rinse formulations and an essential oil containing mouth rinse compared to a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a twelve-week product usage period.

Conditions
Healthy
Being tested
Colgate Cavity Protection Toothpaste, Zero Alcohol Gum Prototype, Alcohol Gum Prototype, Listerine Cool Mint Antiseptic Mouthwash, 5% Hydroalcohol

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.

  • Zero Alcohol Gum PrototypeOther

    Participants will use 20 mL of Zero Alcohol Gum Prototype Mouth Rinse for 30 seconds after brushing twice daily.

  • Alcohol Gum PrototypeOther

    Participants will use 20 mL of Alcohol Gum Prototype Mouth Rinse for 30 seconds after brushing twice daily.

  • Listerine Cool Mint Antiseptic MouthwashOther

    Participants will use 20 mL of Listerine Cool Mint Mouth Rinse for 30 seconds after brushing twice daily.

  • 5% HydroalcoholOther

    Participants will use 20 mL of 5% Hydroalcohol Mouth Rinse for 30 seconds after brushing twice daily.

Study groups in NCT05526586
Study groupRoleWhat they receive
Zero Alcohol Gum PrototypeExperimentalParticipants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 milliliters (mL) of the Zero Alcohol Gum Prototype Mouth Rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Receives: Other: Colgate Cavity Protection Toothpaste; Other: Zero Alcohol Gum Prototype
Alcohol Gum PrototypeExperimentalParticipants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Alcohol Gum Prototype Mouth Rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Receives: Other: Colgate Cavity Protection Toothpaste; Other: Alcohol Gum Prototype
Listerine Cool Mint Antiseptic MouthwashExperimentalParticipants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Listerine Cool Mint Mouth rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Receives: Other: Colgate Cavity Protection Toothpaste; Other: Listerine Cool Mint Antiseptic Mouthwash
Negative Control: 5 percent (%) HydroalcoholActive comparatorParticipants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 mL of the 5% Hydroalcohol Mouth Rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Receives: Other: Colgate Cavity Protection Toothpaste; Other: 5% Hydroalcohol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use

    Gingivitis will be assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).

    Measured: After 12 weeks

  2. Whole-mouth Mean Plaque Index (TPI) Score After 12 Weeks of Product use

    Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than 1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).

    Measured: After 12 weeks

Secondary outcomes (11)

  1. Whole-mouth Mean TPI Score After 1 and 4 Weeks of Product use

    Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin [up to 1 mm], continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than 1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).

    Measured: After Weeks 1 and 4

  2. Whole-mouth Mean MGI Score After 1 and 4 Weeks of Product Use

    Gingivitis will be assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).

    Measured: After 1 and 4 weeks

  3. Whole-Mouth Mean Expanded Gingival Bleeding Index (EBI) Score at 1, 4 and 12 Weeks of Product use

    Bleeding will be assessed according to the EBI, 168 Sites. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).

    Measured: Weeks 1, 4 and 12

  4. Percentage of Bleeding Sites, Based on the EBI Score at 1, 4, and 12 Weeks of Product use

    Percentage of bleeding sites will be calculated by taking the total number of sites with bleeding score greater than 0 divided by the total number of sites assessed for each participant. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).

    Measured: After 1, 4, and Week 12

  5. Whole Mouth Bleeding on Probing Depth at 12 Week

    Whole mouth bleeding on probing depth at 12 week will be reported.

    Measured: At Week 12

  6. Number of Distinct Bacterial Species

    The number of distinct bacterial species identified on supragingival plaque using microbiome profiling will be reported at baseline, 1 week, 4 weeks and 12 weeks.

    Measured: At Baseline and 1, 4, and 12 weeks

  7. Shannon-weaver Diversity Index

    The Shannon-Weaver diversity index will be reported for supragingival plaque assessment.

    Measured: At Baseline and 1, 4, and 12 weeks

  8. Total Species Microbial Load

    The total species microbial load will be reported for supragingival plaque assessment.

    Measured: At Baseline and 1, 4, and 12 weeks

  9. Categorical Species Microbial Load

    The categorical species microbial load will be reported for supragingival plaque assessment.

    Measured: At Baseline and 1, 4, and 12 weeks

  10. Changes in Microbiome Composition by Sample Clustering Analysis

    Clustering analysis in microbiome profiling is a multidimensional reduction analysis for the assessment of microbiome composition shift.

    Measured: At Baseline and 1, 4, and 12 weeks

  11. Number of Live Bacterial Counts Expressed in Log10

    The number of live bacterial counts (expressed in log10) on supragingival and subgingival plaque will be reported at baseline and 12 weeks using viability quantitative polymerase chain reaction (qPCR) targeting total bacteria, Fusobacterium nucleatum, Porphyromonas gingivalis and Actinomyces oris.

    Measured: At Baseline and After 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start31 Aug 2022
  3. Primary completion8 Dec 2022
  4. Study completion8 Dec 2022

Resources

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
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05526586
Sponsor's protocol ID
CCSORC005014
Other IDs
CCSORC005014
Status last verified
Aug 2023
First submitted
31 Aug 2022
Last updated
5 Sep 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Colgate Cavity Protection Toothpaste, Zero Alcohol Gum Prototype and Alcohol Gum Prototype 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 15 inclusion and 20 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 5 Sep 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?

Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use (time frame: After 12 weeks). 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 NCT05526586.

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 5 Sep 2023.

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