Status:
COMPLETED
Investigation of the Safety and Efficacy of Pocket-X Gel
Lead Sponsor:
Tree of Life Pharma Ltd.
Conditions:
Periodontal Pocket
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is an open-label split-mouth study in which Pocket-X Gel, a periodontal in-situ gelling product, will be applied to periodontal pockets in one/two mouth segment(s) of participants, followin...
Detailed Description
This study is an open-label split-mouth study that investigates the safety and efficacy of Pocket-X Gel, a periodontal in-situ gelling product, in improving the healing of the gingiva and preventing b...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Male or female, aged 18 and above
- Provision of up-to-date full mouth periapical x-rays
- Participants suffering from active moderate to severe chronic periodontitis with at least 3 sites of periodontal pockets of 5 mm or greater depth in each quadrant.
- Participants with a minimum of 6 teeth with periodontal pocket depth of more than 5 mm.
- Participants with a minimum of 20 teeth
Exclusion
- Known hypersensitivity to any of the devices components as listed on the user leaflet
- Pregnancy or lactation
- Smoking of more than 9 cigarettes per day
- A concurrent dental disease, except for periodontitis, or planned treatment that may interfere with the study or study intervention, such as dental surgery, teeth implantation, etc.
- Chronic disease such as diabetes mellitus or rheumatoid arthritis
- Aggressive periodontitis
- History of radiotherapy or chemotherapy
- Immunodeficiency or autoimmune disease
- Mental disorders
- Parafunctional habits such as bruxism
- Participant has taken antibiotics in the 6 months prior to the study
- Participant has undergone periodontal treatment 12 months prior to the study
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03358251
Start Date
March 12 2018
End Date
December 30 2019
Last Update
September 2 2020
Active Locations (2)
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1
Dr. Ariel Hirsch Periodontal Clinic
Tel Aviv, Israel
2
Dr. Roni Kolerman Periodontal Clinic
Tel Aviv, Israel