NCT03281109

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1.1 years

First QC Date

August 16, 2017

Last Update Submit

February 5, 2018

Conditions

Keywords

menstrual cyclegingivitisinterleukin 1tumor necrosis factor alpha

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

diagnosisDIAGNOSTIC_TEST

diagnosis with ELISA

Eligibility Criteria

Age20 Years - 29 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly Female
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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)

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • hacer sahin aydinyurt

    yuzuncu yil universtiy

    STUDY DIRECTOR

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

Locations