Ignite Creation Date:
2025-12-25 @ 4:38 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT06254118
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2024-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Periodontitis in Menopausal Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'an independent researcher not directly involved in the study, utilized a computer generated random number sequence to assign participants to either the control or study group. this randomization was executed before the commencement of the treatment phase.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2024-01-28', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'aspartate aminotransferase (AST) in gingival crevicular fluid (GCF).', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'AST in GCF will be measured in 20 participants, evaluation of AST in the collected GCF. The assessment was done using the VITROS Dry Technology 60 Chemistry System which can provide accurate results using even very small amounts of GCF (\\~10 µl). The principle behind the test is to evaluate the enzymatic activity of AST to convert the amino group of aspartates where the oxidation process of nicotinamide adenine dinucleotide (NAD) + hydrogen (H) (NADH+). This activity is measured by the Reflectance Spectrophotometry at 340nm wavelength and 37°C. The change in rate assesses the enzymatic activity as per Bergmeyer et al. method.'}, {'measure': 'Osteocalcin in gingival crevicular fluid (GCF).', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Osteocalcin in GCF, The evaluation of the level of osteocalcin in the GCF sample, using enzyme-linked immunosorbent assay (ELISA) kits (Ani Biotech Oy, AvioBion, Finland), is the next step in the study. The osteocalcin levels are measured in nanograms per milliliter (ng/mL) when assessed using ELISA kits. The principle applied in the sandwich-type ELISA kit is the presence of a monoclonal osteocalcin which is adsorbed onto the well of the kit and then binds to the osteocalcin (present in the sample). The amount of osteocalcin present was assessed using standard curves based on dilutions and measured at the color intensity of 450nm.'}], 'secondaryOutcomes': [{'measure': 'Plaque Index (PI)', 'timeFrame': 'baseline, 6 months, 12 months', 'description': "The PI was conducted according to O'Leary et al. (1972), this precise index records the presence of supra-gingival plaque on all four tooth surfaces. For this test, the plaque is disclosed using a disclosing tablet. and the stained surfaces around the gingival margins were recorded. the presence or absence of plaque is recorded in a simple chart, the plaque incidence in the oral cavity is expressed as an exact percentage, maximum index is 100%, minimum index is 0%."}, {'measure': 'Gingival index (GI)', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'GI was recorded according to Loe and Silness (1963), the gingival index records gingival inflammation in three grades. It is measured on six selected teeth, on facial, lingual, mesial and distal sites. Grades range from 0-3. 0= normal gingiva; no inflammation, no discoloration (erythema), no bleeding. 1= mild inflammation; slight erythema, no bleeding. 2= moderate inflammation; erythema bleeding on probing. (the symptom of bleeding comprises a score of 2). 3= severe inflammation, severe erythema and swelling, tendency to spontaneous bleeding.'}, {'measure': 'Probing pocket depth (PPD)', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'The examination of PPD was conducted using a UNC-15 periodontal probe (UNC-15, Hu-Friedy, Chicago, IL, USA). PPD was measured at 6 points around each tooth Mesiobuccal (MB), midbuccal (B), Distobuccal (DB), Mesiolingual (ML), midlingual (L), and Distolingual (DL).\n\nUNC-15 periodontal probe measures 15mm, PPD of 5mm or more were recorded.'}, {'measure': 'Clinical attachment level (CAL)', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'The examination of CAL was conducted using a UNC-15 periodontal probe (UNC-15, Hu-Friedy, Chicago, IL, USA). CAL was measured at 6 points around each tooth Mesiobuccal (MB), midbuccal (B), Distobuccal (DB), Mesiolingual (ML), midlingual (L), and Distolingual (DL).\n\nUNC-15 periodontal probe measures 15mm, CAL of 1mm or more were recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periodontitis, GCF, Osteocalcin.'], 'conditions': ['Menopausal Patients', 'Chronic Periodontitis', 'Omega 3 Fatty Acids']}, 'referencesModule': {'references': [{'pmid': '38510979', 'type': 'DERIVED', 'citation': 'Eldessouky HF, Marie M. Nonsurgical Treatment of Periodontitis in Menopausal Patients: A Randomized Control Trial. Biomed Res Int. 2024 Mar 13;2024:6997142. doi: 10.1155/2024/6997142. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effectiveness of polyunsaturated fatty acids (PUFAs) \\[omega-3\\] as an adjunctive treatment to scaling and root planing for menopausal women with periodontitis versus scaling and root alone as a non- surgical treatment .\n\n. The main question it aims to answer is:\n\n• to investigate the effect of systemic administration of Omega-3 fatty acids in addition to SRP on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal women.\n\nParticipants will given \\* a soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months along with non-surgical treatment (group2)\n\n\\*\\* a soft gelatin capsules containing olive oil to be consumed directly once daily for 12 months along with non-surgical treatment (group1)\n\nResearchers will compare group 1 to group 2 to see if PUFAs has an effect on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal women. .', 'detailedDescription': "Menopause is typically accompanied by significant systemic and oral manifestations, including hormonal changes and increased susceptibility to periodontal disease, which may involve inflammatory biomarkers like aspartate aminotransferase (AST) and Osteocalcin in gingival crevicular fluid (GCF). The study aims to evaluate the effectiveness of regular inoculation of polyunsaturated fatty acids (PUFAs) as an adjunctive treatment for menopausal women's periodontitis.\n\nMethods: Twenty elderly women with chronic periodontitis were split evenly into two groups by random assignment. Patients in group II (the research group) were given soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months, as opposed to the group I (the control group), who received soft gelatin capsules containing some olive oil (placebo). Scaling and root planning (SRP) were used to address periodontal disease in all cases.\n\nAt baseline, six and twelve months after treatment, clinical indicators and AST and Osteocalcin amounts in the GCF will be noted."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed as; periodontitis patients\n* presence of a minimum of 6 teeth in the mouth\n* at least 3 periodontal sites with probing pocket depth more or equal to 5mm\n* women experiencing menopause for at least a year\n\nExclusion Criteria:\n\n* women suffering from any systemic disorder that might affect the periodontal tissues such as; Diabetes Mellitus, immune disorders,..\n* anemic patients\n* smokers\n* patients taking NSAIDs, supplements, antibiotics regularly used mouthwashes within the last 3 months\n* participants in any other clinical trials'}, 'identificationModule': {'nctId': 'NCT06254118', 'briefTitle': 'Treatment of Periodontitis in Menopausal Patients', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': 'Non-Surgical Treatment of Periodontitis in Menopausal Patients', 'orgStudyIdInfo': {'id': 'HElDessouky'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 2 polyunsaturated fatty acids', 'description': 'intervention: systemic administration of 1000 mg polyunsaturated fatty acids. to be taken once daily with meals for 12 months\n\npatients treated by scaling and root planing and oral systemic administration of Omega-3 fatty acids a soft gelatinous capsule containing 1000 mg polyunsaturated fatty acids (PUFAs)', 'interventionNames': ['Drug: Polyunsaturated Fatty Acids']}, {'type': 'SHAM_COMPARATOR', 'label': 'group 1 control', 'description': 'control group, patients treated by scaling and root planing and an oral soft gelatinous capsule containing olive oil to be taken once daily with meals for 12 months', 'interventionNames': ['Dietary Supplement: olive oil']}], 'interventions': [{'name': 'Polyunsaturated Fatty Acids', 'type': 'DRUG', 'otherNames': ['omega-3 fatty acids'], 'description': '1000mg omega-3 fatty acids taken once daily with meals for 12 months', 'armGroupLabels': ['group 2 polyunsaturated fatty acids']}, {'name': 'olive oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '1000mg olive oil taken once daily with meals for 12 months', 'armGroupLabels': ['group 1 control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeddah', 'state': 'Mecca Region', 'country': 'Saudi Arabia', 'facility': 'King Abdul Aziz University', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'ELDESSOUKY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Abdulaziz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no IPD to be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadir F. El-Dessouky', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor Dr', 'investigatorFullName': 'Hadir F. El-Dessouky', 'investigatorAffiliation': 'King Abdulaziz University'}}}}