Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT02523651
Status:
UNKNOWN
Last Update Posted:
2015-08-14
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Stem Cells Injection Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2015-08-13', 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year', 'timeFrame': 'Baseline and 1 year after intervention.'}], 'secondaryOutcomes': [{'measure': 'Quigley-Hein plaque index (QHI)', 'timeFrame': 'Baseline'}, {'measure': 'Change from Baseline Bleeding on probing (BoP) at 1 year', 'timeFrame': 'Baseline and 1 year after intervention.'}, {'measure': 'Change from Baseline Probing depth (PD) at 1 year', 'timeFrame': 'Baseline and 1 year after intervention.'}, {'measure': 'Change from Baseline Clinical attachment level (CAL) at 1 year', 'timeFrame': 'Baseline and 1 year after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Periodontal Diseases', 'Bone Regeneration', 'Dental Pulp Stem Cell'], 'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of clinical injection of allogeneic human dental pulp stem cell(DPSC) in local infected periodontal tissue and determine whether injection of allogeneic DPSC is a effective way in the treatment of chronic periodontal disease.', 'detailedDescription': 'This study will involve 40 patients who were diagnosed as chronic periodontitis will receive periodontal scaling and root planing. Patients will randomly be divided at the base line into two groups.In test group, 20 chronic periodontitis patients will be treated using local DPSC injection. Whereas, a control group will contain 20 patients who will be treated using placebo. Clinical examination including Quigley-Hein plaque index (QHI), bleeding on probing (BoP), probing depth (PD), clinical attachment level (CAL), and gingival recession (GR) will be perform in different time points during the study. Radiographic and clinical examination will be carried out during the late healing phase up to 12 months post operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of periodontal disease will be based on clinical assessment of:\n\n * Quigley-Hein index (QHI)\n * Bleeding on Probing (BoP)\n * Pocket Probing Depth (PD)\n * gingival recession (GR)\n * Clinical Attachment Level (CAL)\n * furcation involvement,and\n * radiographical assessment. All patients at the base line of this study should have been received the initial treatment and reached the qualified level of oral hygiene to be included in the next stage.\n\nExclusion Criteria:\n\n* Pregnant,\n* smokers,\n* immunosuppressed or diabetes patients,\n* patients exhibit gingival hypertrophy,\n* require premedication, and\n* who have been taking systemic anti-inflammatory medications, or\n* have taken antibiotics or\n* received periodontal instrumentation within 6 months prior to the study, will be excluded.'}, 'identificationModule': {'nctId': 'NCT02523651', 'briefTitle': 'Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Stem Cells Injection Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Study of Local Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Allogeneic Human Dental Pulp Stem Cells Injection Therapy', 'orgStudyIdInfo': {'id': 'CapitalMedicalU-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DPSC injection', 'description': '20 patients will receive DPSC injection（1000000 cells/ 0.5ml） at the local periodontal defects immediately after periodontal scaling and root planing.', 'interventionNames': ['Genetic: DPSC injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo control', 'description': '20 patients will receive saline injection at the local periodontal defects immediately after periodontal scaling and root planing.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'DPSC injection', 'type': 'GENETIC', 'description': 'A 0.5ml saline preparation containing 1000000 DPSCs were injected at the local periodontal defects immediately after periodontal scaling and root planing.', 'armGroupLabels': ['DPSC injection']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'A 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing.', 'armGroupLabels': ['Placebo control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingchao Hu, Ph.D', 'role': 'CONTACT', 'email': 'hujingchao117@hotmail.com', 'phone': '+86 13716607107'}], 'facility': 'Capital Medical University School of Stomatology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Songlin Wang, Ph.D', 'role': 'CONTACT', 'email': 'slwang@ccmu.edu.cn', 'phone': '+86 13601324511'}], 'overallOfficials': [{'name': 'Songlin Wang, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Key Laboratory of Tooth Regeneration and Function Reconstruction， Capital Medical University School of Stomatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Songlin Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Vice President of Capital Medical University', 'investigatorFullName': 'Songlin Wang', 'investigatorAffiliation': 'Capital Medical University'}}}}