Non-Surgical Treatment of Periodontitis in Menopausal Patients

HElDessouky

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 . . The main question it aims to answer is: • 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. Participants will given \* a soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months along with non-surgical treatment (group2) \*\* a soft gelatin capsules containing olive oil to be consumed directly once daily for 12 months along with non-surgical treatment (group1) Researchers 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. .

2020-01-22

2022-01-22

2023-01-30

Completed

Early phase I

20

Inclusion Criteria: * patients diagnosed as; periodontitis patients * presence of a minimum of 6 teeth in the mouth * at least 3 periodontal sites with probing pocket depth more or equal to 5mm * women experiencing menopause for at least a year Exclusion Criteria: * women suffering from any systemic disorder that might affect the periodontal tissues such as; Diabetes Mellitus, immune disorders,.. * anemic patients * smokers * patients taking NSAIDs, supplements, antibiotics regularly used mouthwashes within the last 3 months * participants in any other clinical trials

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2024-02-12