Investigation of the Safety and Efficacy of Pocket-X Gel

Not Applicable

Completed

• Conditions: Periodontal Pocket
• Interventions: Device: Pocket-X Gel; Procedure: Scaling and root planing

• Registration Number: NCT03358251
• Lead Sponsor: Tree of Life Pharma Ltd.

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.

Study Timeline

• Study First Submitted: 2017-11-26
• Study First Submitted QC: 2017-11-26
• Study First Posted: 2017-11-30
• Study Start: 2018-03-12
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Results First Submitted: 2020-06-14
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-17
• Last Update Submitted: 2020-08-17
• Results First Posted: 2020-09-02
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SRP+Pocket-X Gel, split-mouth	Scaling and root planing	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.
SRP+Pocket-X Gel, split-mouth	Pocket-X Gel	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.

Primary Outcome Measures

Name	Time	Method
Change in Periodontal Pockets Probing Depth	12 and 24 weeks following first Pocket-X Gel administration	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

Name	Time	Method
Change in Bleeding Index	12 and 24 weeks following first Pocket-X Gel administration	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 Clinical Attachment	12 and 24 weeks following first Pocket-X Gel administration	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	12 and 24 weeks following first Pocket-X Gel administration	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 Mobility Grade	12 and 24 weeks following first Pocket-X Gel administration	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

Trial Locations

Locations (2)

Dr. Ariel Hirsch Periodontal Clinic; 🇮🇱 Tel Aviv, Israel

Dr. Roni Kolerman Periodontal Clinic; 🇮🇱 Tel Aviv, Israel