An interventional study of Pocket-X Gel and Scaling and root planing in Periodontal Pocket, sponsored by Tree of Life Pharma Ltd.. Completed at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-02.
Sponsored by Tree of Life Pharma Ltd. · Not applicable, Interventional, and Treatment
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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.
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.
130 studies on the registry are indexed under Periodontal Pocket; 35 are open to participants now.
This study's enrollment of 34 is above the median of 30 across 113 interventional studies indexed under Periodontal Pocket.
Browse Periodontal Pocket studies →This is the only study on the registry with Tree of Life Pharma Ltd. as lead sponsor.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Pocket-X Gel · Procedure: Scaling and root planing
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 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.
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.
Time frame: 12 and 24 weeks following first Pocket-X Gel administration
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 12 and 24 weeks following first Pocket-X Gel administration
| Milestone | SRP+Pocket-X Gel, Split-mouth |
|---|---|
| Started | 34 |
| Completed | 34 |
| Not completed | 0 |
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.
| mm | Lower Jaw Pockets + Treatment | Lower Jaw Pockets - Control | Upper Jaw Pockets + Treatment | Upper Jaw Pockets + Control |
|---|---|---|---|---|
| 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 |
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.
| mm | Lower Jaw Pockets + Treatment | Lower Jaw Pockets - Control | Upper Jaw Pockets + Treatment | Upper Jaw Pockets + Control |
|---|---|---|---|---|
| change in CAL after 3 months | 2.08 ± 0.69 | 0.97 ± 0.64 | 2.62 ± 0.82 | 1.26 ± 0.68 |
| change in CAL after 6 months | 3.01 ± 0.92 | 1.06 ± 0.63 | 3.61 ± 0.94 | 1.44 ± 0.83 |
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.
| mm | Lower Jaw Pockets + Treatment | Lower Jaw Pockets - Control | Upper Jaw Pockets + Treatment | Upper Jaw Pockets + Control |
|---|---|---|---|---|
| B recession at baseline | 1.36 ± 1.27 | 1.21 ± 1.17 | 1.49 ± 1.22 | 1.38 ± 1.06 |
| B recession at 3 months | 1.06 ± 1.06 | 1.35 ± 1.32 | 1.01 ± 0.98 | 1.49 ± 1.24 |
| B recession at 6 months | 0.82 ± 0.89 | 1.43 ± 1.42 | 0.80 ± 0.88 | 1.51 ± 1.38 |
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.
| % percent of pockets bleeding | Lower Jaw Pockets + Treatment | Lower Jaw Pockets - Control | Upper Jaw Pockets + Treatment | Upper Jaw Pockets + Control |
|---|---|---|---|---|
| percent of pockets bleeding at baseline | 98.4 | 85.7 | 92.66 | 92.66 |
| percent of pockets bleeding after 3 months | 20.63 | 36.51 | 20.18 | 45.87 |
| percent of pockets bleeding after 6 months | 12.70 | 28.57 | 8.33 | 44.44 |
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
| mobility grade | Lower Jaw Pockets + Treatment | Lower Jaw Pockets - Control | Upper Jaw Pockets + Treatment | Upper Jaw Pockets + Control |
|---|---|---|---|---|
| Mobility at baseline | 0.19 ± 0.50 | 0.19 ± 0.53 | 0.18 ± 0.51 | 0.19 ± 0.52 |
| Mobility after 3 months | 0.05 ± 0.21 | 0.14 ± 0.50 | 0.05 ± 0.23 | 0.15 ± 0.38 |
| Mobility after 6 months | 0 ± 0 | 0.01 ± 0.12 | 0.01 ± 0.10 | 0.12 ± 0.35 |
Collected over until the last visit of the patient, 6 month post the first application of the treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SRP+Pocket-X Gel, Split-mouth | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Age, Continuous(years) | SRP+Pocket-X Gel, Split-mouth |
|---|---|
| Mean | 51.3 ± 13.1 |
| Sex: Female, Male(Participants) | SRP+Pocket-X Gel, Split-mouth |
|---|---|
| Female | 13 |
| Male | 21 |
| Race and Ethnicity Not Collected(Participants) | SRP+Pocket-X Gel, Split-mouth |
|---|
| Region of Enrollment(participants) | SRP+Pocket-X Gel, Split-mouth |
|---|---|
| Israel | 34 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Dec 2019, 21 months.
Results were first posted in Sep 2020, 8 months after primary completion.
Of 63 interventional studies with no phase under Periodontal Pocket, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's 21 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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