N/A
N=34
Investigation of the Safety and Efficacy of Pocket-X Gel
Periodontal Pocket
Bottom Line
View on ClinicalTrials.gov: NCT03358251 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Change in Periodontal Pockets Probing Depth — 6.97; 6.81; 7.67; 7.72 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pocket-X Gel (Device); Scaling and root planing (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tree of Life Pharma Ltd.
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Periodontal Pockets Probing Depth |
6.97; 6.81; 7.67; 7.72; 5.19; 5.69 | — |
| SECONDARY Change in Clinical Attachment |
2.08; 0.97; 2.62; 1.26; 3.01; 1.06 | — |
| SECONDARY Change in Recession Level |
1.36; 1.21; 1.49; 1.38; 1.06; 1.35 | — |
| SECONDARY Change in Bleeding Index |
98.4; 85.7; 92.66; 92.66; 20.63; 36.51 | — |
| SECONDARY Change in Mobility Grade |
0.19; 0.19; 0.18; 0.19; 0.05; 0.14 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT03358251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.