Trial Outcomes & Findings for Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP (NCT NCT05258721)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2025-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	60
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=60 Participants 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.
Age, Continuous	66.2 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

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)

Outcome measures

Outcome measures
Measure	Treatment Group n=52 Participants 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.
Changes in Modified Gingival Index (MGI) Baseline	8.5 score on a scale Interval 4.0 to 16.25
Changes in Modified Gingival Index (MGI) 12 weeks	1.5 score on a scale Interval 0.0 to 4.25

PRIMARY outcome

Timeframe: Baseline and 12 weeks

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=52 Participants 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.
Changes in Plaque Index (PI) Baseline	22.0 score on a scale Interval 15.0 to 40.0
Changes in Plaque Index (PI) 12 weeks	8.0 score on a scale Interval 5.75 to 17.5

PRIMARY outcome

Timeframe: Baseline and 12 weeks

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=52 Participants 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.
Changes in Bleeding On Probing (BOP) Baseline	37.0 percentage of sites with bleeding Interval 29.0 to 45.0
Changes in Bleeding On Probing (BOP) 12 weeks	15.0 percentage of sites with bleeding Interval 10.0 to 24.25

SECONDARY outcome

Timeframe: 90 Days

Adverse events will be collected throughout the study

Outcome measures

Outcome measures
Measure	Treatment Group n=52 Participants 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.
Adverse Events	0 participants

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jai Shewale

Arcadia Consumer Healthcare, Inc.

Phone: 504-913-4344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place