Status:
COMPLETED
The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis
Lead Sponsor:
Rowpar Pharmaceuticals, Inc.
Collaborating Sponsors:
Stony Brook University
Conditions:
Peri-implant Mucositis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 pr...
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 (st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2020
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04838054
Start Date
March 15 2018
End Date
March 4 2020
Last Update
April 14 2022
Active Locations (1)
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1
Stony Brook University
Stony Brook, New York, United States, 11794-8703