Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-06 @ 6:55 PM
Study NCT ID:
NCT02987634
Status:
UNKNOWN
Last Update Posted:
2018-03-14
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation and Comparison of Efficacy of PeriActive Mouthwash to Chlorhexidine 0.12% Mouth Rinse
Sponsor:
Izun Pharma Ltd
Organization:
Study Overview
Official Title:
Phase IV Study to Evaluate and Compare the Efficacy of PeriActive Mouthwash to Chlorhexidine 0.12% Rinse With Regards to Managing Post-surgical Inflammation Associated With Dental Implant Surgery
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
This is a randomized phase IV controlled trial with two parallel arms: (1) PeriActive rinse and (2) Chlorhexidine 0.12% rinse. Subjects will be randomized to one of two treatment groups at the time of implant surgery. An alternating 1:1 randomization scheme will be used, with the first patient receiving Chlorhexidine, the second patient receiving PeriActive, the third patient receiving Chlorhexidine and so forth.
Implant surgery will require an incision and tissue reflection. Implant(s) will be placed at bone level (+/- 2 mm). The abutment placed will be transgingival at least 2 mm above soft tissue level. Tissues will be sutured with 6-0 ePTFE (Goretex) sutures, as needed. Antibiotics will be prescribed for 7 days following surgery. In addition, at the end of the surgical visit, the patient will be issued two bottles of the assigned rinse which will be used twice each day.
Details of Study Visits Screening/Visit 1 - Day 0 Following signing of informed consent form, adult male and female subjects aged ≥18 years will be screened for study eligibility by assessment of inclusion and exclusion criteria. Screening procedures will include collection of demographic data and medical history. Eligible subjects will then undergo implant surgery, and relevant indices will be measured. Subjects will then be instructed in how to rinse with the relevant oral rinse and be given two bottles for the remainder of the study.
Visits 2 and 3 - 2 and 4 weeks (± 3 days) post-surgery, respectively At visit 2, sutures will be removed and a light curetting of the sites (as needed) will be performed, followed by evaluation for Gingival Index (GI; modified for incision), Plaque Index (PI) and compliance with protocol. At visit 3, only clinical indices and compliance with protocol with be evaluated.
Implant surgery will require an incision and tissue reflection. Implant(s) will be placed at bone level (+/- 2 mm). The abutment placed will be transgingival at least 2 mm above soft tissue level. Tissues will be sutured with 6-0 ePTFE (Goretex) sutures, as needed. Antibiotics will be prescribed for 7 days following surgery. In addition, at the end of the surgical visit, the patient will be issued two bottles of the assigned rinse which will be used twice each day.
Details of Study Visits Screening/Visit 1 - Day 0 Following signing of informed consent form, adult male and female subjects aged ≥18 years will be screened for study eligibility by assessment of inclusion and exclusion criteria. Screening procedures will include collection of demographic data and medical history. Eligible subjects will then undergo implant surgery, and relevant indices will be measured. Subjects will then be instructed in how to rinse with the relevant oral rinse and be given two bottles for the remainder of the study.
Visits 2 and 3 - 2 and 4 weeks (± 3 days) post-surgery, respectively At visit 2, sutures will be removed and a light curetting of the sites (as needed) will be performed, followed by evaluation for Gingival Index (GI; modified for incision), Plaque Index (PI) and compliance with protocol. At visit 3, only clinical indices and compliance with protocol with be evaluated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: