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

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Stabilized chlorine dioxide oral rinse
Placebo
Sponsored by
Rowpar Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stony Brook University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test - stabilized chlorine dioxide rinse

Placebo - oral rinse, no active ingredients

Arm Description

Subjects will receive CloSYS Ultra Sensitive Rinse

Subjects will receive oral rinse - no active ingredients

Outcomes

Primary Outcome Measures

Global Probing Depth
The distance measured from the base of the pocket to the most apical point on the gingival margin. Measured in mms. Over 3 mm indicates a need for periodontal therapy. Higher results mean a worse outcome.
Global Plaque Score.
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The index is calculated by dividing the number of plaque-containing surfaces by the total number of available surfaces. Values range from 0-18 with 0 being excellent and 18 poor. Higher numbers mean a worse outcome.
Modified Gingival Index (MGI)
The MGI relies on a visual assessment of gingival changes to measure the severity of inflammation. Five categories, using a 0-4 scale, score the marginal and papillary gingival tissue based on color, texture, edema, and spontaneous bleeding. 0 being normal and 4 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. The higher scores mean a worse outcome.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2021
Last Updated
March 22, 2022
Sponsor
Rowpar Pharmaceuticals, Inc.
Collaborators
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT04838054
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rowpar Pharmaceuticals, Inc.
Collaborators
Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test - stabilized chlorine dioxide rinse
Arm Type
Experimental
Arm Description
Subjects will receive CloSYS Ultra Sensitive Rinse
Arm Title
Placebo - oral rinse, no active ingredients
Arm Type
Placebo Comparator
Arm Description
Subjects will receive oral rinse - no active ingredients
Intervention Type
Drug
Intervention Name(s)
Stabilized chlorine dioxide oral rinse
Intervention Description
Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients received a rinse containing no active ingredients and periodontal basic therapy.
Primary Outcome Measure Information:
Title
Global Probing Depth
Description
The distance measured from the base of the pocket to the most apical point on the gingival margin. Measured in mms. Over 3 mm indicates a need for periodontal therapy. Higher results mean a worse outcome.
Time Frame
90 days
Title
Global Plaque Score.
Description
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The index is calculated by dividing the number of plaque-containing surfaces by the total number of available surfaces. Values range from 0-18 with 0 being excellent and 18 poor. Higher numbers mean a worse outcome.
Time Frame
90 days
Title
Modified Gingival Index (MGI)
Description
The MGI relies on a visual assessment of gingival changes to measure the severity of inflammation. Five categories, using a 0-4 scale, score the marginal and papillary gingival tissue based on color, texture, edema, and spontaneous bleeding. 0 being normal and 4 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. The higher scores mean a worse outcome.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srinivas RM Venkatasatya, DDS, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8703
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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