Treatment of Periodontitis in Menopausal Patients

Hadir F. El-Dessouky

Status and phase: Completed; Phase 4

Conditions: Chronic Periodontitis; Menopausal Patients; Omega 3 Fatty Acids

Treatments: Drug: Polyunsaturated Fatty Acids; Dietary Supplement: olive oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06254118

HElDessouky

Details and patient eligibility

About

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. .

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

group 2 polyunsaturated fatty acids

Experimental group

Description:

intervention: systemic administration of 1000 mg polyunsaturated fatty acids. to be taken once daily with meals for 12 months patients 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)

Treatment:

Drug: Polyunsaturated Fatty Acids

group 1 control

Sham Comparator group

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

Treatment:

Dietary Supplement: olive oil