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

NCT04838054 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00024706
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (3)

• 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.

  90 days

• 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.

  90 days

• 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.

  90 days

Study Arms (2)

Test - stabilized chlorine dioxide rinse

EXPERIMENTAL

Subjects will receive CloSYS Ultra Sensitive Rinse

Drug: Stabilized chlorine dioxide oral rinse

Placebo - oral rinse, no active ingredients

PLACEBO COMPARATOR

Subjects will receive oral rinse - no active ingredients

Other: Placebo

Interventions

Stabilized chlorine dioxide oral rinse DRUG

Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.

Test - stabilized chlorine dioxide rinse

Placebo OTHER

Patients received a rinse containing no active ingredients and periodontal basic therapy.

Placebo - oral rinse, no active ingredients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rowpar Pharmaceuticals, Inc.: lead
• Stony Brook University: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794-8703, United States

Location

Results Point of Contact

• Title: Srinivas Rao Myneni Venkatasatya, DDS, PhD
• Organization: Stony Brook University

srinivas.MyneniVenkatasatya@stonybrookmedicine.edu

631-632-8739

Study Officials

• Srinivas RM Venkatasatya, DDS, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 8, 2021
• Study Start: March 15, 2018
• Primary Completion: January 15, 2020
• Study Completion: March 4, 2020
• Last Updated: April 14, 2022
• Results First Posted: April 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)