Evaluation and Comparison of Efficacy of PeriActive Mouthwash to Chlorhexidine 0.12% Mouth Rinse

NCT02987634 | Unknown Phase 4 DMC

• 1 other identifier: PORPIS
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Izun Pharmaceuticals has shown that PeriActive, an oral rinse containing extracts of Sambucus nigra, Echinacea purpurea, and Centella asiatica significantly reduced gingival inflammation in an experimental gingivitis model in a phase II study, as well as in numerous other clinical trials. The product and its individual components were shown to be safe. Based on these favorable results, Izun is now seeking to demonstrate that a combined anti-bacterial/anti-inflammatory rinse will potentially enhance soft tissue healing and reduce localized inflammation following dental implant surgery equal to, or better than, a chlorhexidine rinse, with fewer side effects.

Conditions

Periodontal Diseases

Keywords

gingivitis; dental implant; mouthwash

Outcome Measures

Primary Outcomes (2)

• GI at buccal margin of implant

  2-4 weeks

• GI at margin of flap adjacent to implant

  2-4 weeks

Study Arms (2)

PeriActive mouthwash

EXPERIMENTAL

patient is directed to rinse twice a day for 4 weeks. each rinse is 15 ml of Periactive

Other: PeriActive

chlorhexidine 0.12% mouthwash

ACTIVE COMPARATOR

patient is directed to rinse twice a day for 4 weeks. each rinse is 10 ml of Periactive

Other: PeriActive

Interventions

PeriActive OTHER

mouthwash

PeriActive mouthwash; chlorhexidine 0.12% mouthwash

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be adult males or females over the age of 18 years.
• Subjects must be able and willing to follow study procedures and instructions.
• Subjects must present with the need for implant surgery that would necessitate surgical incision (flap elevation) and transgingival implant healing cap, be available for follow-up visits and be able to follow rinse protocol instructions.

You may not qualify if:

• Subjects who exhibit gross oral pathology and severe gingival inflammation at the time of surgery at the projected surgical site.
• Subjects chronically treated (i.e., ≥ two weeks) with anti-inflammatory medications (steroids or nonsteroidal anti-inflammatory drugs) or any other medications known to affect gingival tissue status (e.g., phenytoin, cyclosporine) within one month of the screening examination. Prophylactic use of aspirin ( 81 mg daily) and Plavix when used for cardiovascular indications will be permitted (a note should be inserted into patient's documentation) and any therapeutic treatment modifications will be under the jurisdiction of the treating dentist. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment.
• Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
• Subjects with Types I or II diabetes, thyroid disease or cancer chemotherapy
• Subjects reporting allergies to the constituents in the rinse
• Female subjects who report being pregnant or lactating
• Subjects with clinically significant laboratory results

Sponsors & Collaborators

• Izun Pharma Ltd: lead
• Jerusalem Perio Center: collaborator
• Herzog Hospital: collaborator

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Central Study Contacts

Meirav Raz

CONTACT

972-72-245-6199; mraz@izunpharma.com

Motti Levinson

CONTACT

972-72-2458950; motti@izunpharma.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: March 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share