Treatment of Periodontitis in Menopausal Patients

Status Completed

Clinical Trial 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. .

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06254118
Study type	Interventional
Source	King Abdulaziz University
Contact
Status	Completed
Phase	Phase 4
Start date	January 22, 2020
Completion date	January 30, 2023

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.