Periodontal PocketNCT03358251

Investigation of the Safety and Efficacy of Pocket-X Gel

A study testing Pocket-X Gel and Scaling and root planing in people with Periodontal Pocket, run by Tree of Life Pharma Ltd. at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Periodontal Pocket
What is being tested?: Pocket-X Gel and Scaling and root planing
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 2 sitesIsrael
Study dates: 12 Mar 2018to 30 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

Dr. Ariel Hirsch Periodontal Clinic
Tel Aviv
Dr. Roni Kolerman Periodontal Clinic
Tel Aviv

Other trials in Israel

About this study

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

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.

Read the 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
Being tested: Pocket-X Gel, Scaling and root planing
Medical subject headings: Periodontal Pocket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pocket-X GelDevice
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 planingProcedure or surgery
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.

Study groups in NCT03358251
Study group	Role	What they receive
SRP+Pocket-X Gel, split-mouth	Other	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. Receives: Device: Pocket-X Gel; Procedure: Scaling and root planing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 and 24 weeks following first Pocket-X Gel administration

Secondary outcomes (4)

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.
Measured: 12 and 24 weeks following first Pocket-X Gel administration
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.
Measured: 12 and 24 weeks following first Pocket-X Gel administration
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.
Measured: 12 and 24 weeks following first Pocket-X Gel administration
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
Measured: 12 and 24 weeks following first Pocket-X Gel administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 201830 Dec 2019

First posted30 Nov 2017
Study start12 Mar 2018
Primary completion30 Dec 2019
Study completion30 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Periodontal PocketStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03358251
Sponsor's protocol ID: PX-01
Status last verified: Aug 2020
First submitted: 26 Nov 2017
Last updated: 2 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Periodontal Pocket trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03358251
Acronym / sponsor ID: PX-01
Conditions: Periodontal Pocket
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Tree of Life Pharma Ltd.Industry (pharma, biotech, devices)
Study start: 12 Mar 2018 (actual)
Primary completion: 30 Dec 2019 (actual)
Study completion: 30 Dec 2019 (actual)
First posted: 30 Nov 2017 (actual)
Results: Posted 2 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SRP+Pocket-X Gel, split-mouth	Other	Device: Pocket-X Gel, Procedure: Scaling and root planingThis 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pocket-X GelPocket-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.	Device	SRP+Pocket-X Gel, split-mouth
Scaling and root planingScaling 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.	Procedure or surgery	SRP+Pocket-X Gel, split-mouth

Primary outcome

Change in Periodontal Pockets Probing Depth
Time frame: 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.

4 secondary outcomes

Change in Clinical Attachment
Time frame: 12 and 24 weeks following first Pocket-X Gel administration
Change in Recession Level
Time frame: 12 and 24 weeks following first Pocket-X Gel administration
Change in Bleeding Index
Time frame: 12 and 24 weeks following first Pocket-X Gel administration
Change in Mobility Grade
Time frame: 12 and 24 weeks following first Pocket-X Gel administration

Results and safety

Results posted to the registry on 2 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SRP+Pocket-X Gel, Split-mouth	34	34

Primary outcome: Change in Periodontal Pockets Probing Depth

Time frame: 12 and 24 weeks following first Pocket-X Gel administration. Mean (Standard Deviation). Unit: mm

Measure	Lower Jaw Pockets + Treatment n = 34	Lower Jaw Pockets - Control n = 34	Upper Jaw Pockets + Treatment n = 34	Upper Jaw Pockets + Control n = 34
depth at baseline	6.97 (1.49)	6.81 (1.59)	7.67 (1.45)	7.72 (1.30)
depth at 3 months	5.19 (0.98)	5.69 (1.38)	5.53 (1.07)	6.35 (1.10)
depth at 6 months	4.5 (0.8)	5.53 (1.24)	4.74 (0.82)	7.72 (0.99)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: until the last visit of the patient, 6 month post the first application of the treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SRP+Pocket-X Gel, Split-mouth	0 of 34 (0%)	0 of 34 (0%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Periodontal Pocket

Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Not yet recruitingPhase 2
Effect of Gingival Mesenchymal Stem Cell-Derived Small Extracellular Vesicles in Management of Infra-bony Periodontal Defect
Infra-bony Periodontal Defect
Not yet recruiting
Diode Laser 635 nm and 810 nm Photodynamic Therapy as Adjuncts to Non-Surgical Periodontal Treatment
Periodontitis
Not yet recruiting
Clinical Effectiveness of Oxygen-Releasing Oral Gel as an Adjunct to Scaling and Root Debridement in Patients With Severe Periodontal Pockets: A Randomized Clinical Trial
Periodontitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ariel Hirsch principal investigator

Dr. Ariel Hirsch Periodontal Clinic

Roni Kolerman principal investigator

Dr. Roni Kolerman Periodontal Clinic

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pocket-X Gel and Scaling and root planing in people with Periodontal Pocket, run by Tree of Life Pharma Ltd. at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Periodontal Pockets Probing Depth (time frame: 12 and 24 weeks following first Pocket-X Gel administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03358251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.