Menstrual Cycle and Platelet-rich Fibrin

NCT ID: NCT06060574

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-15

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Menstrual Cycle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Menstrual Cycle 1-2nd days

The Blood samples will be drawn from the participants on 1st-2nd day of the menstrual cycle of each of these 36 participants. PRF will be obtained from the blood taken these days.

Platelet rich fibrin device

Intervention Type DEVICE

Within the scope of the study, a total of 2 tubes of venous blood samples will be obtained from the forearm region (antecubital vein) of each individual by the clinical staff specialist nurse of the Department of Periodontology. PRF samples will be created using appropriate equipment and devices from blood samples obtained from each individual. In the study, 10 ml glass-coated plastic tubes will be used. Apart from this, 5 mL of blood taken will be used for complete blood count and evaluation of hormones on the relevant day.

PRF Preparation: In all age groups, PRF will be prepared by centrifugation with 700xg (=2700 rpm, Intra-Spin L-PRF device) for 12 minutes.

Menstrual Cycle 8-10. days : proliferative phase (PP)

The Blood samples will be drawn from the participants on 8-10. days of the menstrual cycle of each of these 36 participants. PRF will be obtained from the blood taken these days.

Platelet rich fibrin device

Intervention Type DEVICE

Within the scope of the study, a total of 2 tubes of venous blood samples will be obtained from the forearm region (antecubital vein) of each individual by the clinical staff specialist nurse of the Department of Periodontology. PRF samples will be created using appropriate equipment and devices from blood samples obtained from each individual. In the study, 10 ml glass-coated plastic tubes will be used. Apart from this, 5 mL of blood taken will be used for complete blood count and evaluation of hormones on the relevant day.

PRF Preparation: In all age groups, PRF will be prepared by centrifugation with 700xg (=2700 rpm, Intra-Spin L-PRF device) for 12 minutes.

Menstrual Cycle 12-14. days: ovulation phase (OP)

The Blood samples will be drawn from the participants on 12-14. days of the menstrual cycle of each of these 36 participants. PRF will be obtained from the blood taken these days.

Platelet rich fibrin device

Intervention Type DEVICE

Within the scope of the study, a total of 2 tubes of venous blood samples will be obtained from the forearm region (antecubital vein) of each individual by the clinical staff specialist nurse of the Department of Periodontology. PRF samples will be created using appropriate equipment and devices from blood samples obtained from each individual. In the study, 10 ml glass-coated plastic tubes will be used. Apart from this, 5 mL of blood taken will be used for complete blood count and evaluation of hormones on the relevant day.

PRF Preparation: In all age groups, PRF will be prepared by centrifugation with 700xg (=2700 rpm, Intra-Spin L-PRF device) for 12 minutes.

premenstrual (PmD) 22-24. days

The Blood samples will be drawn from the participants on 22-24. days of the menstrual cycle of each of these 36 participants. PRF will be obtained from the blood taken these days.

Platelet rich fibrin device

Intervention Type DEVICE

Within the scope of the study, a total of 2 tubes of venous blood samples will be obtained from the forearm region (antecubital vein) of each individual by the clinical staff specialist nurse of the Department of Periodontology. PRF samples will be created using appropriate equipment and devices from blood samples obtained from each individual. In the study, 10 ml glass-coated plastic tubes will be used. Apart from this, 5 mL of blood taken will be used for complete blood count and evaluation of hormones on the relevant day.

PRF Preparation: In all age groups, PRF will be prepared by centrifugation with 700xg (=2700 rpm, Intra-Spin L-PRF device) for 12 minutes.

Interventions

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Platelet rich fibrin device

Within the scope of the study, a total of 2 tubes of venous blood samples will be obtained from the forearm region (antecubital vein) of each individual by the clinical staff specialist nurse of the Department of Periodontology. PRF samples will be created using appropriate equipment and devices from blood samples obtained from each individual. In the study, 10 ml glass-coated plastic tubes will be used. Apart from this, 5 mL of blood taken will be used for complete blood count and evaluation of hormones on the relevant day.

PRF Preparation: In all age groups, PRF will be prepared by centrifugation with 700xg (=2700 rpm, Intra-Spin L-PRF device) for 12 minutes.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Tastan Eroglu

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PRFzeynep

Identifier Type: -

Identifier Source: org_study_id

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