Periodontal Pocket
Conditions
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.
Interventions
DEVICEPocket-X Gel
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.
PROCEDUREScaling and root planing
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.
Sponsors
Tree of Life Pharma Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SRP+Pocket-X Gel, Split-mouth The single 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. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | SRP+Pocket-X Gel, Split-mouth | — |
|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 13.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Israel | 34 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 21 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lower Jaw Pockets + Treatment | Change in Periodontal Pockets Probing Depth | depth at 6 months | 4.5 mm | Standard Deviation 0.8 |
| Lower Jaw Pockets + Treatment | Change in Periodontal Pockets Probing Depth | depth at baseline | 6.97 mm | Standard Deviation 1.49 |
| Lower Jaw Pockets + Treatment | Change in Periodontal Pockets Probing Depth | depth at 3 months | 5.19 mm | Standard Deviation 0.98 |
| Lower Jaw Pockets - Control | Change in Periodontal Pockets Probing Depth | depth at 3 months | 5.69 mm | Standard Deviation 1.38 |
| Lower Jaw Pockets - Control | Change in Periodontal Pockets Probing Depth | depth at baseline | 6.81 mm | Standard Deviation 1.59 |
| Lower Jaw Pockets - Control | Change in Periodontal Pockets Probing Depth | depth at 6 months | 5.53 mm | Standard Deviation 1.24 |
| Upper Jaw Pockets + Treatment | Change in Periodontal Pockets Probing Depth | depth at 3 months | 5.53 mm | Standard Deviation 1.07 |
| Upper Jaw Pockets + Treatment | Change in Periodontal Pockets Probing Depth | depth at baseline | 7.67 mm | Standard Deviation 1.45 |
| Upper Jaw Pockets + Treatment | Change in Periodontal Pockets Probing Depth | depth at 6 months | 4.74 mm | Standard Deviation 0.82 |
| Upper Jaw Pockets + Control | Change in Periodontal Pockets Probing Depth | depth at baseline | 7.72 mm | Standard Deviation 1.3 |
| Upper Jaw Pockets + Control | Change in Periodontal Pockets Probing Depth | depth at 6 months | 7.72 mm | Standard Deviation 0.99 |
| Upper Jaw Pockets + Control | Change in Periodontal Pockets Probing Depth | depth at 3 months | 6.35 mm | Standard Deviation 1.1 |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lower Jaw Pockets + Treatment | Change in Bleeding Index | percent of pockets bleeding after 6 months | 12.70 % percent of pockets bleeding |
| Lower Jaw Pockets + Treatment | Change in Bleeding Index | percent of pockets bleeding after 3 months | 20.63 % percent of pockets bleeding |
| Lower Jaw Pockets + Treatment | Change in Bleeding Index | percent of pockets bleeding at baseline | 98.4 % percent of pockets bleeding |
| Lower Jaw Pockets - Control | Change in Bleeding Index | percent of pockets bleeding after 6 months | 28.57 % percent of pockets bleeding |
| Lower Jaw Pockets - Control | Change in Bleeding Index | percent of pockets bleeding at baseline | 85.7 % percent of pockets bleeding |
| Lower Jaw Pockets - Control | Change in Bleeding Index | percent of pockets bleeding after 3 months | 36.51 % percent of pockets bleeding |
| Upper Jaw Pockets + Treatment | Change in Bleeding Index | percent of pockets bleeding after 3 months | 20.18 % percent of pockets bleeding |
| Upper Jaw Pockets + Treatment | Change in Bleeding Index | percent of pockets bleeding at baseline | 92.66 % percent of pockets bleeding |
| Upper Jaw Pockets + Treatment | Change in Bleeding Index | percent of pockets bleeding after 6 months | 8.33 % percent of pockets bleeding |
| Upper Jaw Pockets + Control | Change in Bleeding Index | percent of pockets bleeding after 6 months | 44.44 % percent of pockets bleeding |
| Upper Jaw Pockets + Control | Change in Bleeding Index | percent of pockets bleeding after 3 months | 45.87 % percent of pockets bleeding |
| Upper Jaw Pockets + Control | Change in Bleeding Index | percent of pockets bleeding at baseline | 92.66 % percent of pockets bleeding |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lower Jaw Pockets + Treatment | Change in Clinical Attachment | change in CAL after 3 months | 2.08 mm | Standard Deviation 0.69 |
| Lower Jaw Pockets + Treatment | Change in Clinical Attachment | change in CAL after 6 months | 3.01 mm | Standard Deviation 0.92 |
| Lower Jaw Pockets - Control | Change in Clinical Attachment | change in CAL after 6 months | 1.06 mm | Standard Deviation 0.63 |
| Lower Jaw Pockets - Control | Change in Clinical Attachment | change in CAL after 3 months | 0.97 mm | Standard Deviation 0.64 |
| Upper Jaw Pockets + Treatment | Change in Clinical Attachment | change in CAL after 3 months | 2.62 mm | Standard Deviation 0.82 |
| Upper Jaw Pockets + Treatment | Change in Clinical Attachment | change in CAL after 6 months | 3.61 mm | Standard Deviation 0.94 |
| Upper Jaw Pockets + Control | Change in Clinical Attachment | change in CAL after 3 months | 1.26 mm | Standard Deviation 0.68 |
| Upper Jaw Pockets + Control | Change in Clinical Attachment | change in CAL after 6 months | 1.44 mm | Standard Deviation 0.83 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lower Jaw Pockets + Treatment | Change in Mobility Grade | Mobility at baseline | 0.19 mobility grade | Standard Deviation 0.5 |
| Lower Jaw Pockets + Treatment | Change in Mobility Grade | Mobility after 6 months | 0 mobility grade | Standard Deviation 0 |
| Lower Jaw Pockets + Treatment | Change in Mobility Grade | Mobility after 3 months | 0.05 mobility grade | Standard Deviation 0.21 |
| Lower Jaw Pockets - Control | Change in Mobility Grade | Mobility at baseline | 0.19 mobility grade | Standard Deviation 0.53 |
| Lower Jaw Pockets - Control | Change in Mobility Grade | Mobility after 6 months | 0.01 mobility grade | Standard Deviation 0.12 |
| Lower Jaw Pockets - Control | Change in Mobility Grade | Mobility after 3 months | 0.14 mobility grade | Standard Deviation 0.5 |
| Upper Jaw Pockets + Treatment | Change in Mobility Grade | Mobility after 3 months | 0.05 mobility grade | Standard Deviation 0.23 |
| Upper Jaw Pockets + Treatment | Change in Mobility Grade | Mobility at baseline | 0.18 mobility grade | Standard Deviation 0.51 |
| Upper Jaw Pockets + Treatment | Change in Mobility Grade | Mobility after 6 months | 0.01 mobility grade | Standard Deviation 0.1 |
| Upper Jaw Pockets + Control | Change in Mobility Grade | Mobility at baseline | 0.19 mobility grade | Standard Deviation 0.52 |
| Upper Jaw Pockets + Control | Change in Mobility Grade | Mobility after 6 months | 0.12 mobility grade | Standard Deviation 0.35 |
| Upper Jaw Pockets + Control | Change in Mobility Grade | Mobility after 3 months | 0.15 mobility grade | Standard Deviation 0.38 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lower Jaw Pockets + Treatment | Change in Recession Level | B recession at baseline | 1.36 mm | Standard Deviation 1.27 |
| Lower Jaw Pockets + Treatment | Change in Recession Level | B recession at 6 months | 0.82 mm | Standard Deviation 0.89 |
| Lower Jaw Pockets + Treatment | Change in Recession Level | B recession at 3 months | 1.06 mm | Standard Deviation 1.06 |
| Lower Jaw Pockets - Control | Change in Recession Level | B recession at baseline | 1.21 mm | Standard Deviation 1.17 |
| Lower Jaw Pockets - Control | Change in Recession Level | B recession at 6 months | 1.43 mm | Standard Deviation 1.42 |
| Lower Jaw Pockets - Control | Change in Recession Level | B recession at 3 months | 1.35 mm | Standard Deviation 1.32 |
| Upper Jaw Pockets + Treatment | Change in Recession Level | B recession at 3 months | 1.01 mm | Standard Deviation 0.98 |
| Upper Jaw Pockets + Treatment | Change in Recession Level | B recession at baseline | 1.49 mm | Standard Deviation 1.22 |
| Upper Jaw Pockets + Treatment | Change in Recession Level | B recession at 6 months | 0.80 mm | Standard Deviation 0.88 |
| Upper Jaw Pockets + Control | Change in Recession Level | B recession at baseline | 1.38 mm | Standard Deviation 1.06 |
| Upper Jaw Pockets + Control | Change in Recession Level | B recession at 6 months | 1.51 mm | Standard Deviation 1.38 |
| Upper Jaw Pockets + Control | Change in Recession Level | B recession at 3 months | 1.49 mm | Standard Deviation 1.24 |