Clinical trial NCT05258721: Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP
Official title: Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on Plaque, Gingival Inflammation and Bleeding Upon Probing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gingivitis
Periodontitis
Keywords: Gingivitis or periodontitis (Stage I or II)
Lead sponsor: Rowpar Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 90-day, self-controlled, longitudinal, non-blinded clinical trial which will measure changes in clinical parameters in participants with gingivitis and Stage I or II periodontitis who apply ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse.

Detailed description: The study will be conducted with 60 medically healthy participants between ages 18 to 75 years with gingival or periodontitis (Stage I or II) who are receiving routine preventive care and/or periodontal maintenance.

Subjects will brush with ClōSYS® Sensitive Fluoride Toothpaste twice daily and rinse with ClōSYS® Sensitive Rinse twice daily after brushing.

The primary response variables will be the Subjects' scores on the Plaque Index (PI), Gingival Index (GI) and the number of sites with bleeding upon probing (BOP). Probing depths and clinical attachment level will be assessed at baseline and 3 months. Adverse events will also be assessed and documented at each visit. In addition, Subjects will keep a usage diary documenting their daily use of the toothpaste and oral rinse and any comments or observations regarding usage or adverse events.

Eligibility criteria: Inclusion Criteria:

* Subjects are between the ages of 18 to 80 years
* Subjects have a minimum of 20 permanent teeth, excluding third molars
* Subjects have been diagnosed with gingivitis or periodontitis (Stages I and II are based on the level of CAL and Bone Loss (BL). The diagnosis is Stage I if: (a) BL is less than 15% and (b) CAL is between 1-2mm. The diagnosis is Stage II if: (a) BL is between 15% and 33% and (b) CAL is between 3-4mm)
* Subjects exhibit bleeding upon probing in \>20% of sites
* Subject is seen every 3 months for routine dental prophylaxis/periodontal maintenance
* Subjects do not have a significant medical history or metabolic diseases (diabetes with A1C ≥ 7.0, pregnancy)
* Subject is currently a non-smoker or has discontinued smoking at least 6 months prior to enrollment
* Subject agrees to refrain from use of the following products: Peridex®, PerioGuard®, Listerine®, Cepacol®, Crest Pro-Health® rinse, Colgate Total® rinse, Colgate Total® toothpaste, Crest Pro Health® toothpaste, or any generic equivalent while participating in this study. Alcohol is not the active ingredient in any oral rinse product and does not produce a significant antibacterial effect
* Subject is able to read and provide written informed consent
* Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations
* Subject agrees not to receive a dental "cleaning" (prophylaxis) while in the study
* Subject must permanently reside in Arizona

Exclusion Criteria:

* Subject has significant medical history or poorly controlled/uncontrolled diabetes (as defined above)
* Subject is pregnant
* Subject has a medical condition that requires antibiotic premedication prior to dental treatment
* Subject has taken antibiotics within 1 month of study enrollment
* Subject who takes multiple medications and/or herbal and dietary supplements known to alter bleeding and exhibits/reports spontaneous gingival bleeding
* Subject takes medications that may interfere with study results (eg. antibiotics, steroids, immunosuppressants, high dose aspirin (325+ mg/day), chemotherapy and/or radiation therapy for cancer).
* Subject is a current smoker
* Subject has a history of non-surgical or surgical periodontal therapy within 6 months of study participation
* Subject has Stage III or IV periodontitis, Grade B or C
* Subject is currently taking or in the past 28 days has taken another investigational drug or participated in other investigational studies that may impact study outcomes
* Subject has not had a dental cleaning within six months prior to the start of the study

Primary outcomes:
measure: Changes in Modified Gingival Index (MGI)
timeFrame: Baseline and 12 weeks
measure: Changes in Plaque Index (PI)
timeFrame: Baseline and 12 weeks
measure: Changes in Probing Depths (PD)
timeFrame: 90 Days
measure: Changes in Clinical Attachment Level (CAL)
timeFrame: 90 Days
measure: Changes in Bleeding On Probing (BOP)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: 90 Days
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona School of Dentistry & Oral Health
state: Arizona
Study officials:
affiliation: Rowpar Pharmaceuticals, Inc.
name: Jaiprakash Shewale, Ph.D.
role: STUDY_DIRECTOR
References: