Clinical trial NCT04838054: The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis
Official title: Pilot Study: The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Peri-implant Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peri-implant Mucositis
Lead sponsor: Rowpar Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stony Brook University
First posted: 2021-04-08
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Global Probing Depth
timeFrame: 90 days
measure: Global Plaque Score.
timeFrame: 90 days
measure: Modified Gingival Index (MGI)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Srinivas RM Venkatasatya, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: