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Antimicrobial Agent

Test - stabilized chlorine dioxide rinse for Peri-implant Mucositis

Phase 4
Waitlist Available
Led By Srinivas RM Venkatasatya, DDS, PhD
Research Sponsored by Rowpar Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days, 45 days, 90 days
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

A full understanding of etiology and diagnosis of peri-implant diseases is crucial for finding effective treatments for these diseases that are more widely accessible to dentists. Several treatment protocols for peri-implant diseases have been proposed, but no gold standard has been established to date. Thus, the purpose of this study is to analyze efficacy of stabilized chlorine dioxide as a chemical adjuvant for treatment of peri-implant mucositis in a non-surgical treatment protocol with a 3-month follow-up.

Eligible Conditions
  • Peri-implant Mucositis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days, 45 days, 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days, 45 days, 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Global Plaque Score.
Global Probing Depth
Modified Gingival Index (MGI)
Secondary study objectives
Reduction in bleeding on probing (BOP)
Turesky modification of the Quigley-Hein Plaque Index (PI)

Side effects data

From 2020 Phase 4 trial • 57 Patients • NCT04838054
3%
Bitterness in the mouth
3%
Unrelated injury
3%
Scheduling Issues
100%
80%
60%
40%
20%
0%
Study treatment Arm
Test - Stabilized Chlorine Dioxide Rinse
Placebo - Oral Rinse, no Active Ingredients

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Test - stabilized chlorine dioxide rinseExperimental Treatment1 Intervention
Subjects will receive CloSYS Ultra Sensitive Rinse
Group II: Placebo - oral rinse, no active ingredientsPlacebo Group1 Intervention
Subjects will receive oral rinse - no active ingredients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stabilized chlorine dioxide oral rinse
2018
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

Rowpar Pharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
313 Total Patients Enrolled
Stony Brook UniversityOTHER
222 Previous Clinical Trials
41,974 Total Patients Enrolled
Srinivas RM Venkatasatya, DDS, PhDPrincipal InvestigatorStony Brook University
~8 spots leftby Oct 2025
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