Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-03 @ 6:11 AM
Study NCT ID:
NCT03358251
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2017-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of the Safety and Efficacy of Pocket-X Gel
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010514', 'term': 'Periodontal Pocket'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tsipi@prudentix.com', 'phone': '+972-72-394-22-24', 'title': 'Head of QA/RA', 'organization': 'Prudentix Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'until the last visit of the patient, 6 month post the first application of the treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'SRP+Pocket-X Gel, Split-mouth', 'description': '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.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Periodontal Pockets Probing Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}, {'units': 'pockets', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Jaw Pockets + Treatment', 'description': 'Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.'}, {'id': 'OG001', 'title': 'Lower Jaw Pockets - Control', 'description': 'Periodontal pockets situated in the lower jaw which received a tratment of SRP only.'}, {'id': 'OG002', 'title': 'Upper Jaw Pockets + Treatment', 'description': 'Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.'}, {'id': 'OG003', 'title': 'Upper Jaw Pockets + Control', 'description': 'Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.'}], 'classes': [{'title': 'depth at baseline', 'categories': [{'measurements': [{'value': '6.97', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '6.81', 'spread': '1.59', 'groupId': 'OG001'}, {'value': '7.67', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '7.72', 'spread': '1.30', 'groupId': 'OG003'}]}]}, {'title': 'depth at 3 months', 'categories': [{'measurements': [{'value': '5.19', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '5.69', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '5.53', 'spread': '1.07', 'groupId': 'OG002'}, {'value': '6.35', 'spread': '1.10', 'groupId': 'OG003'}]}]}, {'title': 'depth at 6 months', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '5.53', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '4.74', 'spread': '0.82', 'groupId': 'OG002'}, {'value': '7.72', 'spread': '0.99', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 and 24 weeks following first Pocket-X Gel administration', 'description': '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.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'pockets', 'denomUnitsSelected': 'pockets'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Attachment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}, {'units': 'pockets', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Jaw Pockets + Treatment', 'description': 'Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.'}, {'id': 'OG001', 'title': 'Lower Jaw Pockets - Control', 'description': 'Periodontal pockets situated in the lower jaw which received a tratment of SRP only.'}, {'id': 'OG002', 'title': 'Upper Jaw Pockets + Treatment', 'description': 'Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.'}, {'id': 'OG003', 'title': 'Upper Jaw Pockets + Control', 'description': 'Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.'}], 'classes': [{'title': 'change in CAL after 3 months', 'categories': [{'measurements': [{'value': '2.08', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '2.62', 'spread': '0.82', 'groupId': 'OG002'}, {'value': '1.26', 'spread': '0.68', 'groupId': 'OG003'}]}]}, {'title': 'change in CAL after 6 months', 'categories': [{'measurements': [{'value': '3.01', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '3.61', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '1.44', 'spread': '0.83', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 and 24 weeks following first Pocket-X Gel administration', 'description': '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.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'pockets', 'denomUnitsSelected': 'pockets'}, {'type': 'SECONDARY', 'title': 'Change in Recession Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}, {'units': 'pockets', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Jaw Pockets + Treatment', 'description': 'Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.'}, {'id': 'OG001', 'title': 'Lower Jaw Pockets - Control', 'description': 'Periodontal pockets situated in the lower jaw which received a tratment of SRP only.'}, {'id': 'OG002', 'title': 'Upper Jaw Pockets + Treatment', 'description': 'Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.'}, {'id': 'OG003', 'title': 'Upper Jaw Pockets + Control', 'description': 'Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.'}], 'classes': [{'title': 'B recession at baseline', 'categories': [{'measurements': [{'value': '1.36', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '1.49', 'spread': '1.22', 'groupId': 'OG002'}, {'value': '1.38', 'spread': '1.06', 'groupId': 'OG003'}]}]}, {'title': 'B recession at 3 months', 'categories': [{'measurements': [{'value': '1.06', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '0.98', 'groupId': 'OG002'}, {'value': '1.49', 'spread': '1.24', 'groupId': 'OG003'}]}]}, {'title': 'B recession at 6 months', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '0.80', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '1.51', 'spread': '1.38', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 and 24 weeks following first Pocket-X Gel administration', 'description': '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.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'pockets', 'denomUnitsSelected': 'pockets'}, {'type': 'SECONDARY', 'title': 'Change in Bleeding Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}, {'units': 'pockets', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Jaw Pockets + Treatment', 'description': 'Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.'}, {'id': 'OG001', 'title': 'Lower Jaw Pockets - Control', 'description': 'Periodontal pockets situated in the lower jaw which received a tratment of SRP only.'}, {'id': 'OG002', 'title': 'Upper Jaw Pockets + Treatment', 'description': 'Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.'}, {'id': 'OG003', 'title': 'Upper Jaw Pockets + Control', 'description': 'Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.'}], 'classes': [{'title': 'percent of pockets bleeding at baseline', 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}, {'value': '92.66', 'groupId': 'OG002'}, {'value': '92.66', 'groupId': 'OG003'}]}]}, {'title': 'percent of pockets bleeding after 3 months', 'categories': [{'measurements': [{'value': '20.63', 'groupId': 'OG000'}, {'value': '36.51', 'groupId': 'OG001'}, {'value': '20.18', 'groupId': 'OG002'}, {'value': '45.87', 'groupId': 'OG003'}]}]}, {'title': 'percent of pockets bleeding after 6 months', 'categories': [{'measurements': [{'value': '12.70', 'groupId': 'OG000'}, {'value': '28.57', 'groupId': 'OG001'}, {'value': '8.33', 'groupId': 'OG002'}, {'value': '44.44', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 and 24 weeks following first Pocket-X Gel administration', 'description': '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.', 'unitOfMeasure': '% percent of pockets bleeding', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'pockets', 'denomUnitsSelected': 'pockets'}, {'type': 'SECONDARY', 'title': 'Change in Mobility Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}, {'units': 'pockets', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Jaw Pockets + Treatment', 'description': 'Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.'}, {'id': 'OG001', 'title': 'Lower Jaw Pockets - Control', 'description': 'Periodontal pockets situated in the lower jaw which received a tratment of SRP only.'}, {'id': 'OG002', 'title': 'Upper Jaw Pockets + Treatment', 'description': 'Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.'}, {'id': 'OG003', 'title': 'Upper Jaw Pockets + Control', 'description': 'Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.'}], 'classes': [{'title': 'Mobility at baseline', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.51', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '0.52', 'groupId': 'OG003'}]}]}, {'title': 'Mobility after 3 months', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '0.15', 'spread': '0.38', 'groupId': 'OG003'}]}]}, {'title': 'Mobility after 6 months', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '0.12', 'spread': '0.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 and 24 weeks following first Pocket-X Gel administration', 'description': '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.\n\nMobility 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).\n\nNormal, 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.\n\nAbnormal, 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.\n\nGrade 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', 'unitOfMeasure': 'mobility grade', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'pockets', 'denomUnitsSelected': 'pockets'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SRP+Pocket-X Gel, Split-mouth', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SRP+Pocket-X Gel, Split-mouth', 'description': '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '51.3', 'spread': '13.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-26', 'size': 839935, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-14T09:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2017-11-26', 'resultsFirstSubmitDate': '2020-06-14', 'studyFirstSubmitQcDate': '2017-11-26', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-17', 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Periodontal Pockets Probing Depth', 'timeFrame': '12 and 24 weeks following first Pocket-X Gel administration', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Clinical Attachment', 'timeFrame': '12 and 24 weeks following first Pocket-X Gel administration', 'description': '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.'}, {'measure': 'Change in Recession Level', 'timeFrame': '12 and 24 weeks following first Pocket-X Gel administration', 'description': '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.'}, {'measure': 'Change in Bleeding Index', 'timeFrame': '12 and 24 weeks following first Pocket-X Gel administration', 'description': '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.'}, {'measure': 'Change in Mobility Grade', 'timeFrame': '12 and 24 weeks following first Pocket-X Gel administration', 'description': '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.\n\nMobility 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).\n\nNormal, 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.\n\nAbnormal, 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.\n\nGrade 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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Pocket']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Male or female, aged 18 and above\n3. Provision of up-to-date full mouth periapical x-rays\n4. 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.\n5. Participants with a minimum of 6 teeth with periodontal pocket depth of more than 5 mm.\n6. Participants with a minimum of 20 teeth\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any of the devices components as listed on the user leaflet\n2. Pregnancy or lactation\n3. Smoking of more than 9 cigarettes per day\n4. 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.\n5. Chronic disease such as diabetes mellitus or rheumatoid arthritis\n6. Aggressive periodontitis\n7. History of radiotherapy or chemotherapy\n8. Immunodeficiency or autoimmune disease\n9. Mental disorders\n10. Parafunctional habits such as bruxism\n11. Participant has taken antibiotics in the 6 months prior to the study\n12. Participant has undergone periodontal treatment 12 months prior to the study'}, 'identificationModule': {'nctId': 'NCT03358251', 'briefTitle': 'Investigation of the Safety and Efficacy of Pocket-X Gel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tree of Life Pharma Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PX-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SRP+Pocket-X Gel, split-mouth', 'description': '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.', 'interventionNames': ['Device: Pocket-X Gel', 'Procedure: Scaling and root planing']}], 'interventions': [{'name': 'Pocket-X Gel', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['SRP+Pocket-X Gel, split-mouth']}, {'name': 'Scaling and root planing', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['SRP+Pocket-X Gel, split-mouth']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Dr. Ariel Hirsch Periodontal Clinic', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Dr. Roni Kolerman Periodontal Clinic', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Ariel Hirsch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Ariel Hirsch Periodontal Clinic'}, {'name': 'Roni Kolerman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Roni Kolerman Periodontal Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tree of Life Pharma Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}