Investigation of the Safety and Efficacy of Pocket-X Gel
1 other identifier
interventional
34
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2017
CompletedFirst Posted
Study publicly available on registry
November 30, 2017
CompletedStudy Start
First participant enrolled
March 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedResults Posted
Study results publicly available
September 2, 2020
CompletedSeptember 2, 2020
August 1, 2020
1.8 years
November 26, 2017
June 14, 2020
August 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Periodontal Pockets Probing Depth
Change in the probing depth of periodontal pockets which have undergone treatment with SRP+Pocket-X Gel in comparison to periodontal pockets which have undergone SRP only.
12 and 24 weeks following first Pocket-X Gel administration
Secondary Outcomes (4)
Change in Clinical Attachment
12 and 24 weeks following first Pocket-X Gel administration
Change in Recession Level
12 and 24 weeks following first Pocket-X Gel administration
Change in Bleeding Index
12 and 24 weeks following first Pocket-X Gel administration
Change in Mobility Grade
12 and 24 weeks following first Pocket-X Gel administration
Study Arms (1)
SRP+Pocket-X Gel, split-mouth
OTHERThis arm is a split-mouth arm, i.e., participants will receive conventional treatment for periodontitis (scaling and root planing) for the entire mouth, and, in addition, will receive experimental treatment (Pocket-X Gel) for periodontal pockets present in one/two mouth segments (quadrants), while the contralateral quadrants will serve as control and will not undergo any further intervention.
Interventions
Pocket-X Gel is a biodegradable in-situ gelling product that is inserted into a pre-cleaned periodontal pocket where it quickly turns into a gel that adheres to the periodontal pocket and acts as a filler and physical barrier against bacterial re-colonization at the site of application. Administration of this product typically causes no discomfort. The product naturally degrades after 1-3 weeks.
Scaling and root planing is a conventional gold-standard treatment for periodontitis. As part of this procedure, subgingival plaque and tartar are removed and root surfaces are planed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dr. Ariel Hirsch Periodontal Clinic
Tel Aviv, Israel
Dr. Roni Kolerman Periodontal Clinic
Tel Aviv, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of QA/RA
- Organization
- Prudentix Ltd.
Study Officials
- PRINCIPAL INVESTIGATOR
Ariel Hirsch
Dr. Ariel Hirsch Periodontal Clinic
- PRINCIPAL INVESTIGATOR
Roni Kolerman
Dr. Roni Kolerman Periodontal Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2017
First Posted
November 30, 2017
Study Start
March 12, 2018
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
September 2, 2020
Results First Posted
September 2, 2020
Record last verified: 2020-08