Clinical trial NCT06254118: Treatment of Periodontitis in Menopausal Patients
Official title: Non-Surgical Treatment of Periodontitis in Menopausal Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopausal Patients
Chronic Periodontitis
Omega 3 Fatty Acids
Keywords: Periodontitis, GCF, Osteocalcin.
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: aspartate aminotransferase (AST) in gingival crevicular fluid (GCF).
timeFrame: baseline, 6 months, 12 months
measure: Osteocalcin in gingival crevicular fluid (GCF).
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Plaque Index (PI)
timeFrame: baseline, 6 months, 12 months
measure: Gingival index (GI)
timeFrame: baseline, 6 months, 12 months
measure: Probing pocket depth (PPD)
timeFrame: baseline, 6 months, 12 months
measure: Clinical attachment level (CAL)
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdul Aziz University
state: Makkah
Study officials:
affiliation: King Abdulaziz University
name: ELDESSOUKY
role: PRINCIPAL_INVESTIGATOR
References: