CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Pocket-X Gel +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03358251
NCT03358251N/ACompleted

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

Tree of Life Pharma Ltd.·interventional·Posted Nov 30, 2017·Updated Sep 2, 2020

In Brief

A clinical study evaluating Pocket-X Gel and Scaling and root planing for Periodontal Pocket. Completed, enrolled 34 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 30, 2017
Enrollment StartMar 12, 2018
Primary CompletionDec 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.6 years ago

Interventions

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

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.