Clinical trial NCT06060574: Menstrual Cycle and Platelet-rich Fibrin
Official title: Effect of the Menstrual Cycle on Levels of Growth Factors From Platelet-rich Fibrin and the Size Outcomes of Membrane
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Menstrual Cycle
Keywords: Menstrual cycle
growth factor
Platelet-rich fibrin
hematological parameters
phases of menstrual cycle
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 36
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Erbakan University Faculty of Dentistry who meet the following inclusion criteria will be included in the study. Eligibility of the individuals to be included in the study. Instructor It will be evaluated at NEU Faculty of Dentistry Periodontology Clinic.

The sample size of the study was calculated with the help of R Statistical Language (version 4.1.2; The R Foundation for Statistical Computing, Vienna, Austria; http://www.r-project.org). In order to determine whether there is a significant difference between the 4 different mestural phases of women in terms of growth factor levels, it was planned to perform the study with at least 36 individuals with 5% significance level, 95% statistical power and 0.25 effect size for Variance analysis in Repeated Measurements.

Brief summary: The goal of this clinical trial is to test effect of menstrual cycle (MC) on growth factors of platelet rich fibrin (PRF) in health condition. The main questions it aims to answer are:

question 1: Does MC have an effect on growth factors in PRF? question 2: In which menstrual phase are growth factors higher? question 3:Does the change in the number of blood cells in the menstrual cycle have an effect on PRF? Participants will describe the main tasks participants will be asked to do.

Detailed description: Abstract Platelet-rich fibrin (PRF) is frequently used in periodontal regenerative treatments. Thanks to the growth factors in its content, it affects the healing positively. Studies have shown that the size and content of PRF are affected by variables such as age, gender, centrifugation speed and inflammation.

It is known that during the menstrual cycle (MS) phases in women, changes occur in cell numbers and growth factors in the blood. The aim of this study is to determine the size of the PRF and the epidermal growth factor (EGF), insulin-like growth factor-1 (IGF-1), platelet-derived growth factor-BB (PDGF-BB), transforming growth factor-β1 (TGF-β1) and vascular endothelial growth factor (VEGF).

PRF membrane will be formed from the blood of each individual in the study, taken on days 1-2 (M), 8-10 (PF), 12-14 (OD) and days 22-24 before menstruation (PmD). The size of the membranes will be measured. On the same days, individuals will have a complete blood count. The growth factors levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined.

At the end of the study, the growth factors contents of the PRF membranes obtained in different phases of MS will be compared. In addition, the effect of the results of the complete blood count of the individuals on the PRF membrane will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Having a regular MS in the last three periods and a menstrual period lasting 5-7 days,
* Not using contraceptive drugs and/or drugs that affect sex hormones,
* With less than 10% bleeding on probing within 10 seconds after probing, that is, gingival ally healthy,
* Have not received any periodontal or orthodontic treatment until at least 6 months before the start of the study,
* Have not used antibiotics in the last 6 months for any reason
* Systemically healthy individuals without prosthetic restoration in their mouths will be included.

Exclusion Criteria:

* Those who have any systemic disease and drug use related to it
* Pregnant or breastfeeding
* have recently used aspirin or have a disease related to the clotting process
* Refusing to participate in the study

Primary outcomes:
measure: Changes in EGF in the obtained PRF during the menstrual cycle
timeFrame: 1 month
measure: Changes in IGF-1 in the obtained PRF during the menstrual cycle
timeFrame: 1 month
measure: Changes in PDGF in the obtained PRF during the menstrual cycle
timeFrame: 1 month
measure: Changes in TGF-beta in the obtained PRF during the menstrual cycle
timeFrame: 1 month
measure: Changes in VEGF in the obtained PRF during the menstrual cycle
timeFrame: 1 month
Secondary outcomes:
measure: Change in the proportion of red blood cells and its effect on PRF.
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
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