NCT06254118

Treatment of Periodontitis in Menopausal Patients

Non-Surgical Treatment of Periodontitis in Menopausal Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hadir F. El-Dessouky · Academic / Other
• Sex: Female
• Age: 45 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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. .

Detailed description

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. Methods: 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. At baseline, six and twelve months after treatment, clinical indicators and AST and Osteocalcin amounts in the GCF will be noted.

Conditions

• Menopausal Patients
• Chronic Periodontitis
• Omega 3 Fatty Acids

Interventions

Type	Name	Description
DRUG	Polyunsaturated Fatty Acids	1000mg omega-3 fatty acids taken once daily with meals for 12 months
DIETARY_SUPPLEMENT	olive oil	1000mg olive oil taken once daily with meals for 12 months

Timeline

• Start date: 2020-01-22
• Primary completion: 2022-01-22
• Completion: 2023-01-30
• First posted: 2024-02-12
• Last updated: 2024-02-12

Locations

1 site across 1 country: Saudi Arabia