Clinical trial NCT03358251: Investigation of the Safety and Efficacy of Pocket-X Gel
Official title: Investigation of the Safety and Efficacy of a Periodontal In-situ Gelling Product, Pocket-X Gel, in the Treatment of Periodontal Pockets Following Scaling and Root Planing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Pocket
Lead sponsor: Tree of Life Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, following scaling and root planing on the entire mouth, while the contralateral segment(s) will serve as control. The aim of the study is to investigate the safety and efficacy of Pocket-X Gel in improving the healing of the gingiva and preventing bacterial re-colonization in the periodontal pocket following scaling and root planing.

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 bacterial re-colonization in the periodontal pocket following scaling and root planing.

The study includes a single arm. All participants will undergo 1-4 sessions of scaling and root planing (SRP), which is the conventional gold-standard treatment for periodontal disease. The number of SRP sessions is dependent on the severity of the periodontal disease. Following completion of SRP, participants will undergo treatment with Pocket-X Gel, which will be inserted into periodontal pockets present in one/two of the participants mouth segments (quadrants), following scaling and root planing. The other mouth segments will not undergo further intervention. The number of segments to be treated is dependent on the clinical symmetry between the treated segment(s) and the contralateral segment(s). Participants will be followed for a total duration of 6 months. Additional application of Pocket-X Gel may occur 1 month and/or 3 months following first application, depending on the state of the participant's periodontal disease.

The rationale for the study is the hypothesis that a physical barrier inserted into periodontal pockets following scaling and root planing would assist in maintaining the pocket clean by preventing bacteria from re-entering the cleaned pocket, thus allowing the gums to properly heal and seal the pockets while preventing further inflammation.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Male or female, aged 18 and above
3. Provision of up-to-date full mouth periapical x-rays
4. 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.
5. Participants with a minimum of 6 teeth with periodontal pocket depth of more than 5 mm.
6. Participants with a minimum of 20 teeth

Exclusion Criteria:

1. Known hypersensitivity to any of the devices components as listed on the user leaflet
2. Pregnancy or lactation
3. Smoking of more than 9 cigarettes per day
4. 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.
5. Chronic disease such as diabetes mellitus or rheumatoid arthritis
6. Aggressive periodontitis
7. History of radiotherapy or chemotherapy
8. Immunodeficiency or autoimmune disease
9. Mental disorders
10. Parafunctional habits such as bruxism
11. Participant has taken antibiotics in the 6 months prior to the study
12. Participant has undergone periodontal treatment 12 months prior to the study

Primary outcomes:
measure: Change in Periodontal Pockets Probing Depth
timeFrame: 12 and 24 weeks following first Pocket-X Gel administration
Secondary outcomes:
measure: Change in Clinical Attachment
timeFrame: 12 and 24 weeks following first Pocket-X Gel administration
measure: Change in Recession Level
timeFrame: 12 and 24 weeks following first Pocket-X Gel administration
measure: Change in Bleeding Index
timeFrame: 12 and 24 weeks following first Pocket-X Gel administration
measure: Change in Mobility Grade
timeFrame: 12 and 24 weeks following first Pocket-X Gel administration
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Dr. Ariel Hirsch Periodontal Clinic
city: Tel Aviv
country: Israel
facility: Dr. Roni Kolerman Periodontal Clinic
Study officials:
affiliation: Dr. Ariel Hirsch Periodontal Clinic
name: Ariel Hirsch
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Roni Kolerman Periodontal Clinic
name: Roni Kolerman
role: PRINCIPAL_INVESTIGATOR
References: