Periodontal Diseases Clinical Trial
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
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.
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.
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