Clinical trial NCT04921371: Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
Official title: Six Week Safety and Clinical Efficacy of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gingivitis
Plaque
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2021-06-10
Enrollment: 157
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 experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage period.


Eligibility criteria: Inclusion Criteria:

* Adequate oral hygiene (That is brush teeth daily and exhibit no signs or oral neglect)
* A minimum of 20 gradable teeth including 4 molars with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, teeth with veneers, 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 (for those in the randomized treatment group)
* A mean gingival index less than or equals to (\<=) 0.75 per the Modified Gingival Index at Baseline (for those in the healthy reference group)
* A mean plaque index \>= 1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index at Baseline (for those in randomized treatment groups)
* Greater than or equal to 10 percent (%) bleeding sites at baseline (for those in randomized treatment groups)

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 Screening/Baseline 1 visit
* More than three sites that have periodontal pockets depths measuring 5mm or greater in depth
* Teeth having periodontal pocket depths measuring more than 3 mm in depth (healthy reference group)
* 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 1 exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator

Primary outcomes:
measure: Whole-mouth Mean Modified Gingival Index (Mean MGI) After 6 Weeks of Product Use
timeFrame: 6 weeks
measure: Whole-mouth Mean Plaque Index (Mean PI) After 6 Weeks of Product Use
timeFrame: 6 weeks
Secondary outcomes:
measure: Whole-mouth Mean Plaque Index (Mean PI) After 4 Weeks of Product Use
timeFrame: 4 weeks
measure: Whole-mouth Mean Modified Gingival Index (Mean MGI) After 4 Weeks of Product Use
timeFrame: 4 weeks
measure: Whole-mouth Mean Expanded Bleeding Index (Mean BI) After 4 and 6 Weeks of Product Use
timeFrame: 4 and 6 Weeks
measure: Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index After 4 and 6 Weeks of Product Use
timeFrame: 4 and 6 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: