Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT06463535
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2024-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level in Periodontitis Patients With Diabetes: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2024-06-09', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum level of chemerin', 'timeFrame': '6 months', 'description': 'Serum level of chemerin'}], 'secondaryOutcomes': [{'measure': 'periodontal clinical parameters', 'timeFrame': '6 months', 'description': 'PD in mm'}, {'measure': 'hba1c', 'timeFrame': '6 months', 'description': 'Glycated Heamoglobin'}, {'measure': 'GCF level of chemerin', 'timeFrame': '6 months', 'description': 'GCF level of chemerin'}, {'measure': 'periodontal clinical parameters', 'timeFrame': '6 months', 'description': 'CAL in mm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Periodontal Diseases']}, 'referencesModule': {'references': [{'pmid': '40771657', 'type': 'DERIVED', 'citation': 'Ghalwash D, Ammar A, Hamdy A, El-Gawish A. Impact of the Adjunctive Use of Omega-3 in Periodontitis Patients With Diabetes on Local and Systemic Chemerin Levels: A Randomized Clinical Trial. Int J Dent. 2025 Jul 30;2025:7927250. doi: 10.1155/ijod/7927250. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Patient grouping\n\n* Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)\n* Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) different clinical parameters were recorded ; plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment loss (CAL).\n\n 6.Omega-3 poly-unsaturated fatty acids (1000mg) was given as an adjunctive treatment daily for 6 months to group 2, starting 2 weeks after phase 1 therapy.', 'detailedDescription': 'A parallel design randomized clinical trial was performed involving thirty participants divided into two groups, 15 participants in each group selected from the outpatient clinic in Oral medicine and Periodontology department.\n\nDiabetic control was assessed by glycosylated hemoglobin A1c (HbA1c) of blood samples, patients had relatively stable glycemic control, as demonstrated by a difference not exceeding 1% in at least two HbA1c assays over the previous 6 m. HbA1c was assessed at baseline, 3m, and 6m.\n\nPatient grouping\n\n* Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)\n* Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) Periodontal treatment protocol\n\nGroup 1 and 2 patients were treated by non-surgical approach in following steps:\n\n1. Each patient had received an initial phase of detailed instruction in self-performed plaque control measures using soft toothbrush and interdental cleansing devices.\n2. Full mouth SRP using ultrasonic scaler and hand instruments under local anesthesia was performed to each patient in two sessions.\n3. Chlorehexidine CHX mouthwash was prescribed for patients to be used twice daily.\n4. For each patient, follow up visits every 2 weeks were done to ensure plaque control.\n5. Patients were re- examined after 2 weeks (baseline), 3 and 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients had type 2 DM for more than 2 years (diagnosed according to the American Diabetes Association criteria), with no other systemic problem. •Subjects had 14 or more natural teeth, of which at least five had a site with probing pocket depth (PPD) ≥ 5 mm and clinical attachment level ≥ 3 mm. From this point, according to the American Academy of Periodontology, subjects with moderate to severe periodontitis were included\n\nExclusion Criteria:\n\n* Pregnant and breastfeeding women, smokers or former smokers, patients with other autoimmune or systemic disease, those patients who took antibiotics in the last 6 months and patients weren't willing to follow our study protocol or plaque regimen"}, 'identificationModule': {'nctId': 'NCT06463535', 'briefTitle': 'Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level in Periodontitis Patients With Diabetes: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level', 'orgStudyIdInfo': {'id': 'BU7720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group I', 'description': 'Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3', 'interventionNames': ['Drug: Omega 3', 'Procedure: SRP alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group II', 'description': 'Type 2 Diabetes Mellitus patients with CPD + SRP', 'interventionNames': ['Procedure: SRP alone']}], 'interventions': [{'name': 'Omega 3', 'type': 'DRUG', 'description': 'SRP + OMEGA 3', 'armGroupLabels': ['group I']}, {'name': 'SRP alone', 'type': 'PROCEDURE', 'description': 'Scaling and root planning', 'armGroupLabels': ['group I', 'group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'British University in Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Ayman El-Gawish', 'investigatorAffiliation': 'British University In Egypt'}}}}