CompletedPhase 4

Treatment of Periodontitis in Menopausal Patients

Saudi Arabia20 participantsStarted 2020-01-22

Plain-language 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. .

Who can participate

Age range

45 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: baseline, 6 months, 12 months

Osteocalcin in gingival crevicular fluid (GCF).

Timeframe: baseline, 6 months, 12 months

Trial details

NCT IDNCT06254118

SponsorHadir F. El-Dessouky

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-22

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