Treatment of Periodontitis in Menopausal Patients

NCT06254118 | Completed Phase 4

• 1 other identifier: HElDessouky
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. .

Conditions

Menopausal Patients; Chronic Periodontitis; Omega 3 Fatty Acids

Keywords

Periodontitis, GCF, Osteocalcin.

Outcome Measures

Primary Outcomes (2)

• aspartate aminotransferase (AST) in gingival crevicular fluid (GCF).

  AST in GCF will be measured in 20 participants, evaluation of AST in the collected GCF. The assessment was done using the VITROS Dry Technology 60 Chemistry System which can provide accurate results using even very small amounts of GCF (\~10 µl). The principle behind the test is to evaluate the enzymatic activity of AST to convert the amino group of aspartates where the oxidation process of nicotinamide adenine dinucleotide (NAD) + hydrogen (H) (NADH+). This activity is measured by the Reflectance Spectrophotometry at 340nm wavelength and 37°C. The change in rate assesses the enzymatic activity as per Bergmeyer et al. method.

  baseline, 6 months, 12 months

• Osteocalcin in gingival crevicular fluid (GCF).

  Osteocalcin in GCF, The evaluation of the level of osteocalcin in the GCF sample, using enzyme-linked immunosorbent assay (ELISA) kits (Ani Biotech Oy, AvioBion, Finland), is the next step in the study. The osteocalcin levels are measured in nanograms per milliliter (ng/mL) when assessed using ELISA kits. The principle applied in the sandwich-type ELISA kit is the presence of a monoclonal osteocalcin which is adsorbed onto the well of the kit and then binds to the osteocalcin (present in the sample). The amount of osteocalcin present was assessed using standard curves based on dilutions and measured at the color intensity of 450nm.

  baseline, 6 months, 12 months

Secondary Outcomes (4)

• Plaque Index (PI)

  baseline, 6 months, 12 months

• Gingival index (GI)

  baseline, 6 months, 12 months

• Probing pocket depth (PPD)

  baseline, 6 months, 12 months

• Clinical attachment level (CAL)

  baseline, 6 months, 12 months

Study Arms (2)

group 2 polyunsaturated fatty acids

EXPERIMENTAL

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)

Drug: Polyunsaturated Fatty Acids

group 1 control

SHAM COMPARATOR

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

Dietary Supplement: olive oil

Interventions

Polyunsaturated Fatty Acids DRUG

1000mg omega-3 fatty acids taken once daily with meals for 12 months

Also known as: omega-3 fatty acids

group 2 polyunsaturated fatty acids

olive oil DIETARY_SUPPLEMENT

1000mg olive oil taken once daily with meals for 12 months

group 1 control

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadir F. El-Dessouky: lead

Study Sites (1)

King Abdul Aziz University

Jeddah, Mecca Region, Saudi Arabia

Location

Related Publications (1)

• Eldessouky HF, Marie M. Nonsurgical Treatment of Periodontitis in Menopausal Patients: A Randomized Control Trial. Biomed Res Int. 2024 Mar 13;2024:6997142. doi: 10.1155/2024/6997142. eCollection 2024.

  PMID: 38510979 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

Fatty Acids, Unsaturated; Fatty Acids, Omega-3; Olive Oil

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• ELDESSOUKY

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 12, 2024
• Study Start: January 22, 2020
• Primary Completion: January 22, 2022
• Study Completion: January 30, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)