The Effect of Menstrual Cycle On IL-6, TNF-α And Periodontal Status
1 other identifier
observational
25
1 country
1
Brief Summary
Aim: Women's menstrual cycle is controlled by the secretion of sex hormones. Sex steroid hormones are thought to be affect to periodontal tissues, wound healing, periodontal disease progression and bone turn over. The aim the study is to evaluate clinical periodontal parameters and interleukin- 6 (IL-6) and tumor necrosis factor alpha (TNF-α) levels in gingival crevicular fluid (GCF) in menstrual cycle. Material and methods: Twenty-five patients were included in this study clinical periodontal parameters and levels of IL-6 and TNF α in gingival crevicular fluid were evaluated at three periods of menstrual cycle (menstruation day (MD)-ovulation day(OD)-premenstruation day (PmD)). Levels of IL-6 and TNF α in gingival crevicular fluid were determined by ELISA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2017
CompletedFirst Submitted
Initial submission to the registry
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
September 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedFebruary 6, 2018
February 1, 2018
1.1 years
August 16, 2017
February 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
periodontal clinical parameters
gingival index: according to Silness and Löe gingival index plaque index: according to Löe and Silness plaque index probing depth the distance between gingival margin to periodontal sulcus bottom (mm) IL-6 concentration (pg/microliter) TNF- alpha concentration (pg/microliter)
1 menstrual cycle (approximately 1 month) every patient follow up
Interventions
diagnosis with ELISA
Eligibility Criteria
25 women were included in this longitudinal, prospective study in Yuzuncu Yil University, Faculty of Dentistry, Department of Periodontology
You may qualify if:
- premenopausal women, age 20-35 to years;
- normal and steady menstrual cycle (25 to 31 days long);
- available for clinical examination;
- non-smoking;
- antibiotic therapy or use of nonsteroidal anti-inflammatory drugs within the past 6 months;
- healthy systemic status;
- normal body mass index;
- healthy periodontium.
You may not qualify if:
- pregnancy;
- use of oral contraceptives;
- metabolic or systemic condition that might affect the periodontium;
- antibiotic therapy or use of nonsteroidal anti-inflammatory drugs within the past 6 months;
- periodontitis;
- smoking and
- with the diagnosis of polycystic over or hyperandrogenism according to Rotterdam diagnostic criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yuzuncu Yıl University
Van, 65080, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
hacer sahin aydinyurt
yuzuncu yil universtiy
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
August 16, 2017
First Posted
September 13, 2017
Study Start
July 26, 2017
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
February 6, 2018
Record last verified: 2018-02