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NCT06254118

Treatment of Periodontitis in Menopausal Patients

Completed Phase 4 Last updated 12 February 2024
What this trial tests

Phase 4 trial testing Polyunsaturated Fatty Acids in Menopausal Patients in 20 participants. Completed in 30 January 2023.

Timeline
22 January 2020
Primary endpoint
22 January 2022
30 January 2023

Quick facts

Lead sponsorHadir F. El-Dessouky
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment20
Start date22 January 2020
Primary completion22 January 2022
Estimated completion30 January 2023
Sites1 location across Saudi Arabia

Drugs / interventions tested

Conditions studied

Sponsor

Hadir F. El-Dessouky — full company profile →

Who can join

Adults 45 to 55, female only, with Menopausal Patients or Chronic Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. .

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Nonsurgical Treatment of Periodontitis in Menopausal Patients: A Randomized Control Trial.
    Eldessouky HF, Marie M. · · 2024 · cited 2× · PMID 38510979 · DOI 10.1155/2024/6997142

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