Clinical trial NCT05526586: A Twelve Week Study of Prototypes Mouth Rinses
Official title: Twelve Week Safety, Clinical, and Microbiological Efficacy of Experimental Zinc Containing Mouth Rinses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 twelve-week product usage period.


Eligibility criteria: Inclusion Criteria:

* 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)
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
timeFrame: After 12 weeks
measure: Whole-mouth Mean Plaque Index (TPI) Score After 12 Weeks of Product use
timeFrame: After 12 weeks
Secondary outcomes:
measure: Whole-mouth Mean TPI Score After 1 and 4 Weeks of Product use
timeFrame: After Weeks 1 and 4
measure: Whole-mouth Mean MGI Score After 1 and 4 Weeks of Product Use
timeFrame: After 1 and 4 weeks
measure: Whole-Mouth Mean Expanded Gingival Bleeding Index (EBI) Score at 1, 4 and 12 Weeks of Product use
timeFrame: Weeks 1, 4 and 12
measure: Percentage of Bleeding Sites, Based on the EBI Score at 1, 4, and 12 Weeks of Product use
timeFrame: After 1, 4, and Week 12
measure: Whole Mouth Bleeding on Probing Depth at 12 Week
timeFrame: At Week 12
measure: Number of Distinct Bacterial Species
timeFrame: At Baseline and 1, 4, and 12 weeks
measure: Shannon-weaver Diversity Index
timeFrame: At Baseline and 1, 4, and 12 weeks
measure: Total Species Microbial Load
timeFrame: At Baseline and 1, 4, and 12 weeks
measure: Categorical Species Microbial Load
timeFrame: At Baseline and 1, 4, and 12 weeks
measure: Changes in Microbiome Composition by Sample Clustering Analysis
timeFrame: At Baseline and 1, 4, and 12 weeks
measure: Number of Live Bacterial Counts Expressed in Log10
timeFrame: At Baseline and After 12 weeks
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc.
state: Indiana
Study officials:
affiliation: Salus Research, Inc.
name: Jeffery Milleman, DDS
role: PRINCIPAL_INVESTIGATOR
References: