Periodontal DiseasesPhase 4NCT02987634
Evaluation and Comparison of Efficacy of PeriActive Mouthwash to Chlorhexidine 0.12% Mouth Rinse
A Phase 4 study testing PeriActive in people with Periodontal Diseases, run by Izun Pharma Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- PeriActive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Periodontal Diseases
- Being tested
- PeriActive
- Keywords
- gingivitis, dental implant, mouthwash
- Medical subject headings
- Periodontal Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeriActiveOther
mouthwash
| Study group | Role | What they receive |
|---|---|---|
| PeriActive mouthwash | Experimental | patient is directed to rinse twice a day for 4 weeks. each rinse is 15 ml of Periactive Receives: 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 Receives: Other: PeriActive |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI at buccal margin of implant
Measured: 2-4 weeks
GI at margin of flap adjacent to implant
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izun Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jerusalem Perio Center, Herzog Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987634
- Sponsor's protocol ID
- PORPIS
- Status last verified
- Mar 2018
- First submitted
- 6 Dec 2016
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: trial results will be published for dentists to see
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02987634
- Acronym / sponsor ID
- PORPIS
- Conditions
- Periodontal Diseases
- Keywords
- gingivitis, dental implant, mouthwash
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Izun Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Jerusalem Perio Center, Herzog Hospital
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PeriActive mouthwash | Experimental | Other: PeriActivepatient is directed to rinse twice a day for 4 weeks. each rinse is 15 ml of Periactive |
| chlorhexidine 0.12% mouthwash | Active comparator | Other: PeriActivepatient is directed to rinse twice a day for 4 weeks. each rinse is 10 ml of Periactive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeriActivemouthwash | Other | PeriActive mouthwash, chlorhexidine 0.12% mouthwash |
Primary outcome
GI at buccal margin of implant
Time frame: 2-4 weeks
GI at margin of flap adjacent to implant
Time frame: 2-4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Individual participant dataSharing planned: No. trial results will be published for dentists to see
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PeriActive in people with Periodontal Diseases, run by Izun Pharma Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meirav Raz (972-72-245-6199, mraz@izunpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI at buccal margin of implant (time frame: 2-4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.