Clinical trial NCT05600231: A Study of Virtually Supervised Mouth Rinses and Flossing
Official title: Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque, Gingivitis, and Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 284
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 efficacy of brushing, flossing, and rinsing with essential oil mouth rinses; brushing and flossing; versus brushing and rinsing with essential oil mouth rinses; and brushing only for the prevention and reduction of plaque and gingivitis.


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 participants has been informed of all pertinent aspects of the trial
* Able to read and understand (participants capable of reading the documents)
* Able to schedule once daily virtual session during weekdays for flossing and rinsing in real time via a platform such as Zoom, Facetime, Google Meet, etc
* Adequate oral hygiene (that is, brush teeth daily and exhibit no signs of oral neglect)
* Adults 18 years of age or 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 childbearing 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 less than or equal to (\<=) 0.75 per the Modified Gingival Index at baseline (healthy reference group)
* A minimum of 10 percent (%) bleeding sites based on the Expanded Bleeding Index (EBI) (randomized treatment groups)
* Participants will have evidence of some gingivitis (mild to severe); there will be no minimum or maximum mean Modified Gingival Index (MGI) score for gingivitis or Turesky Modification of the Quigley Hein Plaque Index (TPI) score for plaque (randomized treatment groups)
* No more than 3 sites having pocket depths of 5 mm and no sites that are greater than 5 millimeters (mm) in depth (randomized treatment groups)
* 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 or other appliances which may interfere with flossing

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; 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)
* Dental prophylaxis within four weeks prior to screening/baseline visit
* History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
* More than or equal to 3% bleeding sites at baseline (healthy reference group)
* Teeth having periodontal pocket depths measuring more than 3mm in depth (healthy reference group)
* Use of antibiotics, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
* Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, stannous fluoride or chlorhexidine containing mouth rinses and toothpastes within four weeks prior to the baseline
* Regular 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
* Suspected alcohol or substance abuse (example, amphetamines, benzodiazepines, cocaine, marijuana, opiates)
* Significant unstable or uncontrolled medical 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 1 or 2 diabetes mellitus
* Participation in any clinical trial within 30 days of the screening/baseline exam
* 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

Primary outcomes:
measure: Interproximal Mean Turesky Plaque Index (TPI) After 12 Weeks of Product Use
timeFrame: After 12 weeks
measure: Interproximal Mean Modified Gingival Index (MGI) After 12 Weeks of Product Use
timeFrame: After 12 weeks
Secondary outcomes:
measure: Marginal Mean TPI After 4 and 12 Weeks
timeFrame: After 4 and 12 weeks
measure: Marginal Mean MGI After 4 and 12 Weeks
timeFrame: After 4 and 12 weeks
measure: Marginal Mean Expanded Bleeding Index (EBI) After 4 and 12 Weeks
timeFrame: After 4 and 12 weeks
measure: Interproximal Mean TPI After 4 Weeks
timeFrame: After 4 weeks
measure: Interproximal Mean MGI After 4 Weeks
timeFrame: 4 weeks
measure: Whole Mouth Mean TPI After 4 and 12 weeks
timeFrame: After 4 and 12 weeks
measure: Whole Mouth Mean MGI After 4 and 12 Weeks
timeFrame: After 4 and 12 weeks
measure: Whole Mouth and Interproximal Mean EBI After 4 and 12 Weeks
timeFrame: After 4 and 12 weeks
measure: Whole Mouth and Interproximal Percent Bleeding Sites After 4 and 12 Weeks based on EBI
timeFrame: After 4 and 12 weeks
measure: Whole Mouth and Interproximal Mean Pocket Depth After 12 Weeks
timeFrame: After 12 weeks
measure: Whole Mouth and Interproximal Mean Bleeding Upon Probing Pocket Depths After 12 Weeks
timeFrame: After 12 weeks
measure: Shannon-Weaver Diversity Index
timeFrame: At baseline and 4 and 12 weeks
measure: Total Species Microbial Load
timeFrame: At baseline and 4 and 12 weeks
measure: Categorical Species Microbial Load
timeFrame: At baseline and 4 and 12 weeks
measure: Bacterial Species Richness
timeFrame: At baseline and 4 and 12 weeks
measure: Changes in Microbiome Composition by Multidimensional Reduction Analysis
timeFrame: At baseline and 4 and 12 weeks
measure: Number of Live Bacterial Counts Expressed in Log10
timeFrame: Up to 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:
citation: Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167.
citation: Sharma N, Charles CH, Lynch MC, Qaqish J, McGuire JA, Galustians JG, Kumar LD. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504. doi: 10.14219/jada.archive.2004.0217.
citation: Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.
citation: Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387.
citation: Rich SK, Friedman JA, Schultz LA. Effects of flossing on plaque and gingivitis in third grade schoolchildren. J Public Health Dent. 1989 Spring;49(2):73-7. doi: 10.1111/j.1752-7325.1989.tb02029.x.
citation: Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.
citation: Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989 Jan;24(1):75-80. doi: 10.1111/j.1600-0765.1989.tb00860.x.
citation: CHILTON NW. Studies in the design and analysis of dental experiments. II. A four-way analysis of variance. J Dent Res. 1960 Mar-Apr;39:344-60. doi: 10.1177/00220345600390021601. No abstract available.
citation: Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.
citation: Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.