Clinical trial NCT05121909: A Study of Experimental Mouthwashes
Official title: Twelve Week Safety/Clinical/Microbiological Efficacy of Experimental Mouthwashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Plaque
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2021-11-16
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and efficacy of experimental mouthwash formulations compared to a hydroalcohol control mouthwash and a positive control mouthwash 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 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 to 59 years of age, in good general and oral health without any known allergy to commercial dental products or cosmetics
* 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 (men do not have to use a medically acceptable method of birth control before or during 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 at baseline
* 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 moderate/advanced periodontitis based on a clinical examination and discretion of the dental examiner
* 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, mouthwashes and red food dye
* Dental prophylaxis within four weeks prior to Baseline visit
* More than three sites that have periodontal pockets depths measuring 5 millimeters (mm) 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, calcium channel blockers, 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) is 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)
* 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 participants 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 2 diabetes mellitus
* 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 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
* Coronavirus Disease 2019 (COVID-19) restrictions: a) History of a confirmed COVID-19 infection in the last 30 days; b) Contact with a COVID-19-infected person within 14 days prior to enrollment; c) Any international travel within 14 days prior to enrollment including members in the same household; d) Participants with self-reported symptoms within the past 2 weeks: i) Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomach aches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever or chest pain/tightness; ii) Temperature \>= 38.0 degree Celsius (°C)/100.4 degree Fahrenheit (°F), measured by thermometer which is adjusted for core temperature; iii) Use of fever reducers within the past 2 days of each onsite visit

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 Turesky 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 1 and 4 weeks
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
timeFrame: 1, 4 and 12 weeks
measure: Percentage of Bleeding Sites, Based on the EBI Score at 1, 4 and 12 Weeks
timeFrame: 1, 4 and 12 weeks
measure: Log10 Transformed Total Bacterial Count After 4 and 12 Weeks of Product use
timeFrame: After 4 and 12 weeks
measure: Log10 Transformed Bacterial Counts After 4 and 12 Weeks of Product use
timeFrame: After 4 and 12 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: All Sum Research Center Ltd.; 6635 Kitimat Road, Units 36 & 37
state: Ontario, Canada
Study officials:
affiliation: All Sum Research Center Ltd.
name: Chhaju Ram Goyal, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Araujo MWB, Charles CA, Weinstein RB, McGuire JA, Parikh-Das AM, Du Q, Zhang J, Berlin JA, Gunsolley JC. Meta-analysis of the effect of an essential oil-containing mouthrinse on gingivitis and plaque. J Am Dent Assoc. 2015 Aug;146(8):610-622. doi: 10.1016/j.adaj.2015.02.011.
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: 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: 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: 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: Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387
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.