The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Intervention: Stabilized chlorine dioxide oral rinse; Placebo
Intervention description: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.; Patients received a rinse containing no active ingredients and periodontal basic therapy.
Intervention MeSH terms: Chlorine dioxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will receive an Oral Hygiene Kit at Visit 1. The MGI, BOP and PI, Pocket depth and radiographs will be measured and all oral tissues examined (baseline examination). Subjects will return for Visit 2 in 14 days ± 3 days to: 1) assess and record changes in indices and oral health and any adverse conditions. Visit 3 (45 days ± 7) will be a compliance visit for study drug utilization. Visit 4 (90 days ± 7) will be a repeat of Visit 1.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Once a subject has been screened and qualified for study participation, that subject will be enrolled and assigned the next available randomization number. The study randomization table will be generated by a third-party statistician. This procedure will be used to keep the Study Statistician blinded to subject treatments prior to database lock.
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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