Investigation of the Safety and Efficacy of Pocket-X Gel

NCT ID: NCT03358251

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2019-12-30

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.

Conditions

Periodontal Pocket

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SRP+Pocket-X Gel, split-mouth

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.

Group Type: OTHER

Pocket-X Gel

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

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.

Interventions

Pocket-X Gel

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: DEVICE

Scaling and root planing

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tree of Life Pharma Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariel Hirsch

Role: PRINCIPAL_INVESTIGATOR

Dr. Ariel Hirsch Periodontal Clinic

Roni Kolerman

Role: PRINCIPAL_INVESTIGATOR

Dr. Roni Kolerman Periodontal Clinic

Locations

Dr. Ariel Hirsch Periodontal Clinic

Tel Aviv, , Israel

Dr. Roni Kolerman Periodontal Clinic

Tel Aviv, , Israel

Countries

Israel

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PX-01

Identifier Type: -

Identifier Source: org_study_id