NCT04838054

The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis

Pilot Study: The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Peri-implant Mucositis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Rowpar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Fifty individuals with peri-implant mucositis will be identified to participate in this study and randomized into two groups to analyze clinical parameters and results of this study: 1) test group (stabilized chlorine dioxide rinse) and 2) control group (placebo). Each group will be associated with periodontal basic therapy. Treatment Protocol After inclusion of the patients, medical history and initial examination are performed, patients will be randomly divided into the following two groups: 1) test (stabilized chlorine dioxide rinse associated with periodontal basic therapy); and 2) control (placebo associated with periodontal basic therapy). Periodontal basic therapy will consist of oral hygiene instruction, motivation, retentive factor removal, and an adaptation of the protocol of full-mouth scaling and root planing (stabilized chlorine dioxide mouthwash will be used). Plastic currets are used to instrument the implants and metal currets to instrument teeth. Immediately after instrumentation, chemical solutions of chlorine dioxide or placebo will be dispensed to the subjects. The subjects will follow their normal oral-hygiene procedures with the addition of using the study rinse toothbrush and toothpaste provided to them.

Conditions

• Peri-implant Mucositis

Interventions

Type	Name	Description
DRUG	Stabilized chlorine dioxide oral rinse	Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.
OTHER	Placebo	Patients received a rinse containing no active ingredients and periodontal basic therapy.

Timeline

• Start date: 2018-03-15
• Primary completion: 2020-01-15
• Completion: 2020-03-04
• First posted: 2021-04-08
• Last updated: 2022-04-14
• Results posted: 2022-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study