Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClōSYS® Sensitive Fluoride Toothpaste | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events will be collected throughout the study | 90 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaiprakash Shewale, Ph.D. | Rowpar Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona School of Dentistry & Oral Health | Mesa | Arizona | 85206 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | 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. ClōSYS® Sensitive Fluoride Toothpaste: 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. ClōSYS® Sensitive Rinse: ClōSYS® Sensitive Rinse is a cosmetic product containing 0.1% stabilized chlorine dioxide. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 12 weeks |
|
From Baseline Visit 1 to End of the study Visit 3 (12 weeks/3 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jai Shewale | Arcadia Consumer Healthcare, Inc. | 504-913-4344 | jshewale@arcadiach.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2020 | Feb 7, 2023 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ClōSYS® Sensitive Rinse | Other | ClōSYS® Sensitive Rinse is a cosmetic product containing 0.1% stabilized chlorine dioxide. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 12 weeks |
|
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | percentage of sites with bleeding | Baseline and 12 weeks |
|
|
|
|
| Secondary | Adverse Events | Adverse events will be collected throughout the study | Posted | Number | participants | 90 Days |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
Not provided
Not provided
| D009057 |
| Stomatognathic Diseases |