GingivitisPhase 2NCT05258721
Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP
A Phase 2 study testing ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse in people with Gingivitis and Periodontitis, run by Rowpar Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gingivitis, Periodontitis
- What is being tested?
- ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2021to 31 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona School of Dentistry & Oral Health
Mesa, Arizona, 85206
About this study
Official title: Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on Plaque, Gingival Inflammation and Bleeding Upon Probing
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.
Read the 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.
- Conditions
- Gingivitis, Periodontitis
- Being tested
- ClōSYS® Sensitive Fluoride Toothpaste, ClōSYS® Sensitive Rinse
- Keywords
- Gingivitis or periodontitis (Stage I or II)
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClōSYS® Sensitive Fluoride ToothpasteDrug
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 RinseOther
ClōSYS® Sensitive Rinse is a cosmetic product containing 0.1% stabilized chlorine dioxide.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ClōSYS® Sensitive Fluoride Toothpaste; Other: ClōSYS® Sensitive Rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Adverse Events
Adverse events will be collected throughout the study
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start6 Jul 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowpar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaiprakash Shewale, Ph.D., Study director, Rowpar Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258721
- Sponsor's protocol ID
- ATSU-RPR-Oral rinse 2020
- Status last verified
- Jul 2025
- First submitted
- 17 Feb 2022
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on Plaque, Gingival Inflammation and Bleeding Upon Probing
- ClinicalTrials.gov ID
- NCT05258721
- Acronym / sponsor ID
- ATSU-RPR-Oral rinse 2020
- Conditions
- Gingivitis, Periodontitis
- Keywords
- Gingivitis or periodontitis (Stage I or II)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rowpar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Posted 15 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: ClōSYS® Sensitive Fluoride Toothpaste, Other: ClōSYS® Sensitive RinseParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClōSYS® Sensitive Fluoride ToothpasteClōSYS® 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. | Drug | Treatment Group |
| ClōSYS® Sensitive RinseClōSYS® Sensitive Rinse is a cosmetic product containing 0.1% stabilized chlorine dioxide. | Other | Treatment Group |
Primary outcome
Changes in Modified Gingival Index (MGI)
Time frame: 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)
Changes in Plaque Index (PI)
Time frame: 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.
Changes in Bleeding On Probing (BOP)
Time frame: 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.
1 secondary outcome
Adverse Events
Time frame: 90 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaiprakash Shewale, Ph.D. study director
Rowpar Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse in people with Gingivitis and Periodontitis, run by Rowpar Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Modified Gingival Index (MGI) (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.