Trial · NCT05258721
Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP
NCT05258721, Phase 2, Completed, Rowpar Pharmaceuticals, Inc.; results first posted 2023-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP. Trials, record NCT05258721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05258721
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP
- NCT number
- NCT05258721
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Rowpar Pharmaceuticals, Inc.
- Conditions
- Gingivitis, Periodontitis
- Interventions
- ClōSYS® Sensitive Fluoride Toothpaste, ClōSYS® Sensitive Rinse
- First posted
- 2022-02-28
- Last updated
- 2025-08-15
- Results first posted
- 2023-03-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Modified Gingival Index (MGI) | 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) |
| Primary | Changes in Plaque Index (PI) | 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. |
| Primary | Changes in Bleeding On Probing (BOP) | 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. |
| Secondary | Adverse Events | 90 Days | Adverse events will be collected throughout the study |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Modified Gingival Index (MGI) | Baseline and 12 weeks | score on a scale | MEDIAN | |
| PRIMARY | Changes in Plaque Index (PI) | Baseline and 12 weeks | score on a scale | MEDIAN | |
| PRIMARY | Changes in Bleeding On Probing (BOP) | Baseline and 12 weeks | percentage of sites with bleeding | MEDIAN | |
| SECONDARY | Adverse Events | 90 Days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Modified Gingival Index (MGI) | Treatment Group | Baseline | 8.5 | Inter-Quartile Range 4.0 to 16.25 | score on a scale |
| Changes in Modified Gingival Index (MGI) | Treatment Group | 12 weeks | 1.5 | Inter-Quartile Range 0.0 to 4.25 | score on a scale |
| Changes in Plaque Index (PI) | Treatment Group | Baseline | 22.0 | Inter-Quartile Range 15.0 to 40.0 | score on a scale |
| Changes in Plaque Index (PI) | Treatment Group | 12 weeks | 8.0 | Inter-Quartile Range 5.75 to 17.5 | score on a scale |
| Changes in Bleeding On Probing (BOP) | Treatment Group | Baseline | 37.0 | Inter-Quartile Range 29.0 to 45.0 | percentage of sites with bleeding |
| Changes in Bleeding On Probing (BOP) | Treatment Group | 12 weeks | 15.0 | Inter-Quartile Range 10.0 to 24.25 | percentage of sites with bleeding |
| Adverse Events | Treatment Group | 0 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group | 60 | |
| Overall Study | COMPLETED | Treatment Group | 52 | |
| Overall Study | NOT COMPLETED | Treatment Group | 8 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group | 0 | 60 |
| Total, other adverse events | Treatment Group | 0 | 60 |
| Total, serious adverse events | Treatment Group | 0 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05258721
GET https://conductscience.org/api/trials/v1/NCT05258721/registered