Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-07 @ 6:44 AM
Study NCT ID:
NCT03810560
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2019-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erbium Chromium: YSGG Laser Effect on Surgical Treatment of Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-04', 'studyFirstSubmitDate': '2019-01-05', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Assessment of Plaque index(PI)', 'timeFrame': '6 months', 'description': 'Visual Analog Score for plaque for detection amount of plaque accumulation so assess patient oral hygiene.\n\nrecording is based on both soft and mineralized debris. Each surface will have a score from 0 to 3. 0: no plaque\n\n1. plaque only detected by probe.\n2. Moderate deposits detected by naked eye.\n3. heavy deposits detected by naked eye.'}, {'measure': 'Clinical Assessment of Gingival index(GI) to assess gingival inflammation. 0: normal gingiva. 1: mild inflammation . 2: moderate inflammation . 3: sever inflammation marked redness and edema and spontaneous bleeding.', 'timeFrame': '6 months', 'description': 'Visual Analog Score for gingival inflammation'}, {'measure': 'Clinical Assessment of Probing depth (PD).', 'timeFrame': '6 months', 'description': 'measured by milli meters for detection of level of periodontal destruction.'}, {'measure': 'Clinical Assessment of Clinical attachment level (CAL) .', 'timeFrame': '6 months', 'description': 'measured by milli meters for detection of level of periodontal destruction.'}, {'measure': 'Clinical Assessment of Gingival recession(GR)', 'timeFrame': '6 months', 'description': 'measured by milli meters for detection of level of apical migration of gingival attachment.'}, {'measure': 'Clinical Assessment of Modified sulcular bleeding index (MSBI)', 'timeFrame': '6 months', 'description': 'Visual Analog Score of bleeding for detection of inflammatory status level. Modified Sulcus Bleeding Index(MSBI) 0 = No bleeding on bleeding.\n\n1. =pin pointed bleeding.\n2. = linear bleeding.\n3. = Heavy or profuse bleeding.'}], 'secondaryOutcomes': [{'measure': 'Microbiological assessment through real time PCR assay for quantification of total bacterial load by universal probe and primer set (16sr RNA)', 'timeFrame': '3 months', 'description': 'quantification of total bacterial load'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generalized Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'Microbiological and Clinical assessment of Er,Cr:YSGG laser in conjunction to open flap debridement (OFD) in treatment of chronic periodontitis through real time PCR assay for quantification of total bacterial load.', 'detailedDescription': 'Two groups are randomly allocated (random number generation) by Microsoft excel into two groups :\n\n1. Group (1) Open Flap debridement (OFD) surgery after conventional periodontal therapy (Scaling \\&Curettage and root planing) combined by Er,Cr:YSGG Laser assisted pocket therapy (ELAPT) which will be applied to pocket epithelial lining and root surface.\n2. Group (2) Open Flap debridement (OFD) surgery after conventional periodontal therapy (Scaling \\&Curettage and root planing) will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are diagnosed to have chronic periodontitis, having infrabony posterior periodontal pocket measuring 5 mm or more.\n* female or male.\n* 25 - 55 years.\n* Medically controlled according to medical coding of review of systems .\n* Patient without history of drug administration in last month .\n\nExclusion criteria:\n\n* Tobacco smoking.\n* Pregnancy.\n* Patients not follow periodontal hygienic instructions.\n* Patients under any medication that affect periodontal healing.\n* The presence of any systemic disease that affect periodontal healing.'}, 'identificationModule': {'nctId': 'NCT03810560', 'briefTitle': 'Erbium Chromium: YSGG Laser Effect on Surgical Treatment of Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Microbiological and Clinical Assessments of Erbium Chromium: YSGG Laser as an Adjunctive to Surgical Treatment of Chronic Periodontitis (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'PER16-30M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'open flap debridement', 'description': 'surgical treatment of periodontal pocket without any intervention'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laser device with open flap debridement', 'description': 'surgical intervention associated with application of Erbium chromium: YSGG laser therapy', 'interventionNames': ['Device: laser device Er,Cr:YSGG laser']}], 'interventions': [{'name': 'laser device Er,Cr:YSGG laser', 'type': 'DEVICE', 'description': 'laser device with open flap debridement', 'armGroupLabels': ['laser device with open flap debridement']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'alaa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'alaa', 'investigatorAffiliation': 'Ain Shams University'}}}}