Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-31 @ 12:57 PM
Study NCT ID:
NCT06784869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-20
First Post:
2025-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Scaling and Root Planing on Endothelin-1 Level
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PPD', 'timeFrame': '3 months recall visits', 'description': 'changes in PPD after non-surgical periodontal treatment.'}, {'measure': 'CAL', 'timeFrame': '3 months recall visits', 'description': 'changes in CAL after non-surgical periodontal treatment.'}], 'secondaryOutcomes': [{'measure': 'ET-1', 'timeFrame': '3 months recall visits', 'description': 'change in GCF level of Endothelin-1 in 1- and 3- month following the periodontal treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontitis', 'endotheiln-1', 'scaling and root surface debritment'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases.\n\nAim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy.\n\nMaterial and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.', 'detailedDescription': 'Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases.\n\nAim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy.\n\nMaterial and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemically healthy\n* Generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm)\n\nExclusion Criteria:\n\n* subjects who wore dental prosthesis\n* teeth with grade II mobility,\n* alcoholic and smoker, had treated caries\n* underwent periodontal therapy within the last four months'}, 'identificationModule': {'nctId': 'NCT06784869', 'acronym': 'clinical', 'briefTitle': 'The Efficacy of Scaling and Root Planing on Endothelin-1 Level', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'The Efficacy of Scaling and Root Planing on Endothelin-1 Gingival Crevicular Fluid Levels Among Periodontitis Patients: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '1/10/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'have generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm).', 'description': 'got generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm) will undergo scaling and root surface debritment', 'interventionNames': ['Device: Scaling and root surface debritment']}], 'interventions': [{'name': 'Scaling and root surface debritment', 'type': 'DEVICE', 'otherNames': ['Scaling and root planing'], 'description': 'Patients with 4-6 mm pocket depth were participated in this study; clinical periodontal parameters (BOP, PLI, PPD, CAL) were recorded at the baseline visit. To ensure sampling accuracy, From the site two papers with GCF were sampled. Following sample collecting for GCF, Every patient received comprehensive mouth supragingival scaling with an ultrasonic scaler (WoodpEEKer® UDS-K) along with dental hygiene recommendations. One week later, the sites were irrigated with normal saline after being scaled and root planed (ScRp) with Gracey curette. Following completion of subgingival instrumentation, each patient returned to the clinic following 1 and 3 months for periodontal parameter recording and GCF collection. Throughout these sessions, every patient received reinstruction to engage in self-oral hygiene practices.', 'armGroupLabels': ['have generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm).']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sarah alrihaymee', 'role': 'CONTACT', 'email': 'sarra.anwar1205a@codental.uobaghdad.edu.iq', 'phone': '07828802375'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of periodontic department', 'investigatorFullName': 'Sarah Alrihaymee', 'investigatorAffiliation': 'University of Baghdad'}}}}