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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04712630 -
Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft
|
N/A | |
| Recruiting |
NCT03997552 -
NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration
|
N/A | |
| Completed |
NCT04478864 -
Knowledge, Practice and State of Periodontal Health
|
||
| Completed |
NCT03507868 -
YKL-40 and IL-6 Levels in Periodontal Disease
|
||
| Completed |
NCT05720481 -
Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels
|
N/A | |
| Recruiting |
NCT06052150 -
Oral Health In Cirrhosis of the Liver (ORACLE)
|
||
| Recruiting |
NCT06025955 -
Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Furcation Involvement.
|
N/A | |
| Recruiting |
NCT03510702 -
SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS
|
||
| Completed |
NCT05631600 -
Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT05068778 -
Development of an AI App to Improve Compliance in Periodontal Maintenance Patients
|
||
| Not yet recruiting |
NCT05178563 -
Mechanisms of Acute Inflammation Following Periodontal Treatment
|
N/A | |
| Recruiting |
NCT06224699 -
Toothpaste With Sodium Carbonate in Patients With Gingivitis
|
N/A | |
| Recruiting |
NCT06086821 -
Clinical Relevance of Different Time of Periodontal Re-evaluation
|
N/A | |
| Not yet recruiting |
NCT05721313 -
Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study
|
N/A | |
| Completed |
NCT06306937 -
Serum Levels of Vitamin D and IL8 in Patients With Periodontitis
|
||
| Completed |
NCT06040944 -
Antipsychotic Induced Hyperprolactinemaia as Risk Factor for Periodontitis in Schizophrenic Patients
|
||
| Recruiting |
NCT04669717 -
Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies
|
Phase 4 | |
| Completed |
NCT05576142 -
Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
|
||
| Completed |
NCT04017078 -
Assessment of Carotid Artery Calcifications
|
||
| Not yet recruiting |
NCT03588507 -
Clinical and Radiographic Evaluation of PPF With or Without NCHA Bone in Treatment of Intrabony Defects
|
N/A |