Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-06 @ 3:26 PM
Study NCT ID:
NCT05555420
Status:
UNKNOWN
Last Update Posted:
2022-09-26
First Post:
2022-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMP-2 and ALP Levels Following Laser Therapy With Scaling and Root Planing in Periodontitis- RCT.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-22', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of attachment gain', 'timeFrame': '3 months', 'description': 'Described in mm'}], 'secondaryOutcomes': [{'measure': 'Level of BMP-2 in GCF', 'timeFrame': '3 months', 'description': 'ELISA test'}, {'measure': 'Level of ALP in GCF', 'timeFrame': '3 months', 'description': 'Colorimetry'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Periodontitis, Laser']}, 'descriptionModule': {'briefSummary': 'Patients with periodontitis will be treated by either SRP only or SRP in combination with laser.\n\nSamples from GCF will be collected immediately after treatment and at 3 months follow-up time. Levels of BMP-2 and ALP will be assessed at these time points.\n\nStatistical analysis to compare the results will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Periodontitis\n\nExclusion Criteria:\n\n* Uncontrolled medical condition'}, 'identificationModule': {'nctId': 'NCT05555420', 'briefTitle': 'BMP-2 and ALP Levels Following Laser Therapy With Scaling and Root Planing in Periodontitis- RCT.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of BMP-2 and ALP Levels Following Laser Therapy as an Adjunct to Scaling and Root Planing for Treatment of Periodontitis- A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'ACU-Dentistry-Perio.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SRP only', 'interventionNames': ['Device: SRP+Laser']}, {'type': 'EXPERIMENTAL', 'label': 'SRP+Laser', 'interventionNames': ['Device: SRP+Laser']}], 'interventions': [{'name': 'SRP+Laser', 'type': 'DEVICE', 'description': 'Non-surgical periodontal therapy in combination with Laser', 'armGroupLabels': ['SRP only', 'SRP+Laser']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Marwa El Sayed Abbas Ahmed', 'investigatorAffiliation': 'Ahram Canadian University'}}}}