Investigation of the Safety and Efficacy of Pocket-X Gel

Periodontal Pocket Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358251
• Other study ID #: PX-01
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2020
• Source: Tree of Life Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Pocket

Intervention

Device:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
Israel	Dr. Ariel Hirsch Periodontal Clinic	Tel Aviv
Israel	Dr. Roni Kolerman Periodontal Clinic	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tree of Life Pharma Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 and 24 weeks following first Pocket-X Gel administration
Secondary	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.	12 and 24 weeks following first Pocket-X Gel administration
Secondary	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.	12 and 24 weeks following first Pocket-X Gel administration
Secondary	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	12 and 24 weeks following first Pocket-X Gel administration