Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-06 @ 7:06 AM
Study NCT ID:
NCT05419102
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2022-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'targetDuration': '7 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2022-06-10', 'studyFirstSubmitQcDate': '2022-06-10', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retention of the implant', 'timeFrame': '0.71 to 6.4 years', 'description': 'Determine if the implant was still present at the time of reevaluation'}], 'secondaryOutcomes': [{'measure': 'record the clinical condition of the implant at the time of reevaluation', 'timeFrame': '0.71 to 6.4 years', 'description': 'Multiple standard measurements of the clinical condition of the implant were recorded at the time of reevaluation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental implant', 'peri-implantitis', 'enamel matrix derivative'], 'conditions': ['Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant Treatment']}, 'descriptionModule': {'briefSummary': 'The existing records of a private practice limited to the practice of periodontology were reviewed to locate patients who had been diagnosed with peri-implantitis (failing dental implant) and had been surgically treated utilizing enamel matrix derivative (Commercially available FDA product Emdogain sold by Straumann USA). Various clinical factors were gathered from the existing records. Some of the factors recorded were: retention of the implant, presence of bleeding, presence of further damage, and presence of inflammation. All patients had signed an informed consent for treatment and the anonymous use of their data for research purposes. All HIPA requirements were followed.', 'detailedDescription': 'See brief summary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Routine adult patients in a private periodontal practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all adult patients of record who presented with existing peri-implantitis that was clinically deemed treatable (the implant was not considered hopeless.)\n\nExclusion Criteria:\n\n* none except for routine medical contraindications for periodontal surgery'}, 'identificationModule': {'nctId': 'NCT05419102', 'briefTitle': 'Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)', 'organization': {'class': 'OTHER', 'fullName': 'North Dallas Dental Health'}, 'officialTitle': 'Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)', 'orgStudyIdInfo': {'id': 'EMD Implant 1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'peri-implantitis surgery with enamel matrix derivative', 'type': 'PROCEDURE', 'description': 'surgical procedures around dental implants with peri-implantits to remove infectious material and apply enamel matrix derivative to the implant.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75221', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'North Dallas Dental Health', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Thomas G Wilson', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Dallas Dental Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Private Practitioner', 'investigatorFullName': 'Thomas G Wilson, Jr. DDS', 'investigatorAffiliation': 'North Dallas Dental Health'}}}}