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

• Status: Completed
• Trial end date: 2020-03-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rowpar Pharmaceuticals, Inc.
• Collaborator: Stony Brook University
• Treatments: Chlorine dioxide

Criteria

Inclusion Criteria:

• diagnosis of peri-implant mucositis

• at least one implant

• probing depth (PD) ≤5mm

• BOP (bleeding on probing)

• No radiographic evidence of bone loss beyond the first two threads of the implant

Exclusion Criteria:

• Active Periodontitis or Peri-implantitis which requires definitive treatment.

• Presence of oral local mechanical factors that could (in the opinion of the PI) influence the outcome of the study.

• Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.

• Presence of soft or hard tissue tumors of the oral cavity.

• Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 12 weeks prior to study entry and throughout the study duration.

• Patients chronically (i.e. two weeks or more) treated with non-steroidal anti-inflammatory drugs (NSAIDs) or any medications know to affect soft tissue condition (excluding treatment of Acetylsalicylic acid ≤ 100 mg/day).

• Patients with uncontrolled diabetes, of any type, and/or patients with HbA1c test value >7.5% dated 3 months prior to the screening visit.

• Patients receiving radiation therapy to the head and neck area and/or receiving immunosuppressive therapy.

• The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.

• Drug and alcohol abuse.

• Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.

• Subject is pregnant (based on pregnancy result) or lactating.

• Subject is a smoker, or has been a smoker within the past 6 months.

• Any other condition that may interfere with the study as judged by the PI