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Investigation of the Safety and Efficacy of Pocket-X Gel

Primary Purpose

Periodontal Pocket

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pocket-X Gel
Scaling and root planing
Sponsored by
Tree of Life Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Pocket

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Ariel Hirsch Periodontal Clinic
  • Dr. Roni Kolerman Periodontal Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SRP+Pocket-X Gel, split-mouth

Arm Description

This 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Clinical Attachment
Change in the clinical attachment level of mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only.
Change in Recession Level
Change in gingival recession level (buccal) of mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only. Measured in mm.
Change in Bleeding Index
Change in gingival bleeding index of mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only.
Change in Mobility Grade
Change in mobility grade of teeth present in mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only. Mobility is graded clinically by applying pressure with the ends of 2 metal instruments (e.g. dental mirrors) and trying to rock a tooth gently in a bucco-lingual direction (towards the tongue and outwards again). Normal, physiologic tooth mobility of about 0.25 mm is present in health. This is because the tooth is not fused to the bones of the jaws, but is connected to the sockets by the periodontal ligament. Abnormal, pathologic tooth mobility occurs when the attachment of the periodontal ligament to the tooth is reduced (attachment loss), or if the periodontal ligament is inflamed. Tooth mobility is measured and graduated from 0-3. Grade 0: No apparent mobility Grade 1: Perceptible mobility <1mm in buccolingual direction Grade 2: >1mm but <2mm Grade 3: >2mm or depressibility in the socket

Full Information

First Posted
November 26, 2017
Last Updated
August 17, 2020
Sponsor
Tree of Life Pharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03358251
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tree of Life Pharma Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRP+Pocket-X Gel, split-mouth
Arm Type
Other
Arm Description
This 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.
Intervention Type
Device
Intervention Name(s)
Pocket-X Gel
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Periodontal Pockets Probing Depth
Description
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.
Time Frame
12 and 24 weeks following first Pocket-X Gel administration
Secondary Outcome Measure Information:
Title
Change in Clinical Attachment
Description
Change in the clinical attachment level of mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only.
Time Frame
12 and 24 weeks following first Pocket-X Gel administration
Title
Change in Recession Level
Description
Change in gingival recession level (buccal) of mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only. Measured in mm.
Time Frame
12 and 24 weeks following first Pocket-X Gel administration
Title
Change in Bleeding Index
Description
Change in gingival bleeding index of mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only.
Time Frame
12 and 24 weeks following first Pocket-X Gel administration
Title
Change in Mobility Grade
Description
Change in mobility grade of teeth present in mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only. Mobility is graded clinically by applying pressure with the ends of 2 metal instruments (e.g. dental mirrors) and trying to rock a tooth gently in a bucco-lingual direction (towards the tongue and outwards again). Normal, physiologic tooth mobility of about 0.25 mm is present in health. This is because the tooth is not fused to the bones of the jaws, but is connected to the sockets by the periodontal ligament. Abnormal, pathologic tooth mobility occurs when the attachment of the periodontal ligament to the tooth is reduced (attachment loss), or if the periodontal ligament is inflamed. Tooth mobility is measured and graduated from 0-3. Grade 0: No apparent mobility Grade 1: Perceptible mobility <1mm in buccolingual direction Grade 2: >1mm but <2mm Grade 3: >2mm or depressibility in the socket
Time Frame
12 and 24 weeks following first Pocket-X Gel administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel Hirsch
Organizational Affiliation
Dr. Ariel Hirsch Periodontal Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roni Kolerman
Organizational Affiliation
Dr. Roni Kolerman Periodontal Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Ariel Hirsch Periodontal Clinic
City
Tel Aviv
Country
Israel
Facility Name
Dr. Roni Kolerman Periodontal Clinic
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Investigation of the Safety and Efficacy of Pocket-X Gel

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