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Completed

NCT Number: NCT06254118

Treatment of Periodontitis in Menopausal Patients

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. .

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Key information

Conditions

Menopausal Patients Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Omega 3 Fatty Acids Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

King Abdul Aziz University

Jeddah, Mecca Region, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyunsaturated Fatty Acids

Drug

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

Other names: omega-3 fatty acids

Olive Oil

Dietary Supplement

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

Primary outcomes

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

    Time frame: baseline, 6 months, 12 months

    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.

  2. Osteocalcin in gingival crevicular fluid (GCF).

    Time frame: baseline, 6 months, 12 months

    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.

Secondary outcomes

  1. Plaque Index (PI)

    Time frame: baseline, 6 months, 12 months

    The PI was conducted according to O'Leary et al. (1972), this precise index records the presence of supra-gingival plaque on all four tooth surfaces. For this test, the plaque is disclosed using a disclosing tablet. and the stained surfaces around the gingival margins were recorded. the presence or absence of plaque is recorded in a simple chart, the plaque incidence in the oral cavity is expressed as an exact percentage, maximum index is 100%, minimum index is 0%.

  2. Gingival index (GI)

    Time frame: baseline, 6 months, 12 months

    GI was recorded according to Loe and Silness (1963), the gingival index records gingival inflammation in three grades. It is measured on six selected teeth, on facial, lingual, mesial and distal sites. Grades range from 0-3. 0= normal gingiva; no inflammation, no discoloration (erythema), no bleeding. 1= mild inflammation; slight erythema, no bleeding. 2= moderate inflammation; erythema bleeding on probing. (the symptom of bleeding comprises a score of 2). 3= severe inflammation, severe erythema and swelling, tendency to spontaneous bleeding.

  3. Probing pocket depth (PPD)

    Time frame: baseline, 6 months, 12 months

    The examination of PPD was conducted using a UNC-15 periodontal probe (UNC-15, Hu-Friedy, Chicago, IL, USA). PPD was measured at 6 points around each tooth Mesiobuccal (MB), midbuccal (B), Distobuccal (DB), Mesiolingual (ML), midlingual (L), and Distolingual (DL).

    UNC-15 periodontal probe measures 15mm, PPD of 5mm or more were recorded.

  4. Clinical attachment level (CAL)

    Time frame: baseline, 6 months, 12 months

    The examination of CAL was conducted using a UNC-15 periodontal probe (UNC-15, Hu-Friedy, Chicago, IL, USA). CAL was measured at 6 points around each tooth Mesiobuccal (MB), midbuccal (B), Distobuccal (DB), Mesiolingual (ML), midlingual (L), and Distolingual (DL).

    UNC-15 periodontal probe measures 15mm, CAL of 1mm or more were recorded.

Sponsors and collaborators

Lead sponsor

Hadir F. El-Dessouky

Other

Registry information

Official study title

Non-Surgical Treatment of Periodontitis in Menopausal Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 12, 2024
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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