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Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP

Primary Purpose

Gingivitis, Periodontitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ClōSYS® Sensitive Fluoride Toothpaste
ClōSYS® Sensitive Rinse
Sponsored by
Rowpar Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Gingivitis or periodontitis (Stage I or II)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects are between the ages of 18 to 75 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

Sites / Locations

  • Arizona School of Dentistry & Oral Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Participants with gingivitis or periodontitis (Stage I or II) brush with ClōSYS® Sensitive Fluoride Toothpaste twice daily and rinse with ClōSYS® Sensitive Rinse twice daily after brushing.

Outcomes

Primary Outcome Measures

Changes in Modified Gingival Index (MGI)
MGI uses a rating score between 0 and 4, with 0 indicating a tooth with healthy gums and 4 the most severe inflammation. MGI scores were determined by visual exam of the gingiva on 4 surfaces for each tooth present except for third molars, for a total of 28 teeth. The total number of teeth exhibiting inflammation affecting all portions of the gingival unit (Score ≥ 2) were noted at each visit. The total number of teeth affected was evaluated for each visit in the final analysis. At baseline: Score range is (0-64) At 12 weeks: Score range is (0-32)
Changes in Plaque Index (PI)
The PI was recorded on all teeth except for third molars. PI was recorded on 4 surfaces of each tooth. PI uses a rating score between 0 and 3, with 0 indicating no plaque in gingival area and 3 heavy accumulation of plaque. Total score is reported. At baseline: Score range is 9 -157. At 12 weeks: Score range is 1 -147.
Changes in Probing Depths (PD)
PD at six sites per tooth for all teeth
Changes in Clinical Attachment Level (CAL)
CAL will be measured from the CEJ to the base of the pocket at 6 sites per tooth
Changes in Bleeding On Probing (BOP)
Bleeding On Probing (BOP) will be recorded as a dichotomous variable (present/absent) during the periodontal examination. The percentage of sites that bleed will be calculated by dividing the number of sites with bleeding by the total number of sites.

Secondary Outcome Measures

Adverse Events
Adverse events will be collected throughout the study

Full Information

First Posted
February 17, 2022
Last Updated
February 17, 2023
Sponsor
Rowpar Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05258721
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rowpar Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Periodontitis
Keywords
Gingivitis or periodontitis (Stage I or II)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Participants with gingivitis or periodontitis (Stage I or II) brush with ClōSYS® Sensitive Fluoride Toothpaste twice daily and rinse with ClōSYS® Sensitive Rinse twice daily after brushing.
Intervention Type
Drug
Intervention Name(s)
ClōSYS® Sensitive Fluoride Toothpaste
Intervention Description
ClōSYS® Sensitive Fluoride Toothpaste is an over-the-counter drug product containing 0.12% stabilized chlorine dioxide (sodium chlorite in an aqueous solution) and 0.13% w/v fluoride ion.
Intervention Type
Other
Intervention Name(s)
ClōSYS® Sensitive Rinse
Intervention Description
ClōSYS® Sensitive Rinse is a cosmetic product containing 0.1% stabilized chlorine dioxide.
Primary Outcome Measure Information:
Title
Changes in Modified Gingival Index (MGI)
Description
MGI uses a rating score between 0 and 4, with 0 indicating a tooth with healthy gums and 4 the most severe inflammation. MGI scores were determined by visual exam of the gingiva on 4 surfaces for each tooth present except for third molars, for a total of 28 teeth. The total number of teeth exhibiting inflammation affecting all portions of the gingival unit (Score ≥ 2) were noted at each visit. The total number of teeth affected was evaluated for each visit in the final analysis. At baseline: Score range is (0-64) At 12 weeks: Score range is (0-32)
Time Frame
Baseline and 12 weeks
Title
Changes in Plaque Index (PI)
Description
The PI was recorded on all teeth except for third molars. PI was recorded on 4 surfaces of each tooth. PI uses a rating score between 0 and 3, with 0 indicating no plaque in gingival area and 3 heavy accumulation of plaque. Total score is reported. At baseline: Score range is 9 -157. At 12 weeks: Score range is 1 -147.
Time Frame
Baseline and 12 weeks
Title
Changes in Probing Depths (PD)
Description
PD at six sites per tooth for all teeth
Time Frame
90 Days
Title
Changes in Clinical Attachment Level (CAL)
Description
CAL will be measured from the CEJ to the base of the pocket at 6 sites per tooth
Time Frame
90 Days
Title
Changes in Bleeding On Probing (BOP)
Description
Bleeding On Probing (BOP) will be recorded as a dichotomous variable (present/absent) during the periodontal examination. The percentage of sites that bleed will be calculated by dividing the number of sites with bleeding by the total number of sites.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Adverse events will be collected throughout the study
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaiprakash Shewale, Ph.D.
Organizational Affiliation
Rowpar Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona School of Dentistry & Oral Health
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP

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