Phase 4
N=57
The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis
Peri-implant Mucositis
Bottom Line
View on ClinicalTrials.gov: NCT04838054 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Global Probing Depth — 2.37; 2.64 mm — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Stabilized chlorine dioxide oral rinse (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rowpar Pharmaceuticals, Inc.
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Probing Depth |
2.37; 2.64 | 0.28 |
| PRIMARY Global Plaque Score. |
1.57; 1.98 | 0.011 sig |
| PRIMARY Modified Gingival Index (MGI) |
1.48; 1.52 | <0.001 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04838054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.