Menstrual CycleNCT06060574
Menstrual Cycle and Platelet-rich Fibrin
An observational study of Menstrual Cycle, run by Necmettin Erbakan University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Menstrual Cycle
- What is being tested?
- Platelet rich fibrin device
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Effect of the Menstrual Cycle on Levels of Growth Factors From Platelet-rich Fibrin and the Size Outcomes of Membrane
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.
Read the 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.
- Conditions
- Menstrual Cycle
- Being tested
- Platelet rich fibrin device
- Keywords
- Menstrual cycle, growth factor, Platelet-rich fibrin, hematological parameters, phases of menstrual cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrin deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Platelet rich fibrin device | |
| 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. Receives: Device: Platelet rich fibrin device | |
| 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. Receives: Device: Platelet rich fibrin device | |
| 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. Receives: Device: Platelet rich fibrin device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in EGF in the obtained PRF during the menstrual cycle
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). EGF levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined.
At the end of the study, EGF contents of the PRF membranes obtained in different phases of MS will be compared.
Measured: 1 month
Changes in IGF-1 in the obtained PRF during the menstrual cycle
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). IGF-1 levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined.At the end of the study, IGF-1 contents of the PRF membranes obtained in different phases of MS will be compared.
Measured: 1 month
Changes in PDGF in the obtained PRF during the menstrual cycle
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). PDGF levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined.
At the end of the study, PDGF contents of the PRF membranes obtained in different phases of MS will be compared.
Measured: 1 month
Changes in TGF-beta in the obtained PRF during the menstrual cycle
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). TGF-beta levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined.
At the end of the study, TGF-beta contents of the PRF membranes obtained in different phases of MS will be compared.
Measured: 1 month
Changes in VEGF in the obtained PRF during the menstrual cycle
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). VEGF levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined.
At the end of the study, VEGF contents of the PRF membranes obtained in different phases of MS will be compared.
Measured: 1 month
Secondary outcomes (1)
Change in the proportion of red blood cells and its effect on PRF.
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).At the same time, complete blood count of the participants will be done. Changes in the proportion of red blood cells throughout MS will be examined. The effect of changes in the proportion of red blood cells on PRF size will be evaluated. PRF length and width will be measured in mm. The proportion of red blood cells will be evaluated with hematocrit level, an instrument for measuring the ratio of the volume of red blood cells to the total volume of blood.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start15 Jun 2024 (estimated)
- Primary completion28 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Tastan Eroglu, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060574
- Sponsor's protocol ID
- PRFzeynep
- Status last verified
- Apr 2024
- First submitted
- 1 Sep 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Menstrual Cycle on Levels of Growth Factors From Platelet-rich Fibrin and the Size Outcomes of Membrane
- ClinicalTrials.gov ID
- NCT06060574
- Acronym / sponsor ID
- PRFzeynep
- Conditions
- Menstrual Cycle
- Keywords
- Menstrual cycle, growth factor, Platelet-rich fibrin, hematological parameters, phases of menstrual cycle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 28 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Menstrual Cycle 1-2nd days | – | Device: Platelet rich fibrin deviceThe 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. |
| Menstrual Cycle 8-10. days : proliferative phase (PP) | – | Device: Platelet rich fibrin deviceThe 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. |
| Menstrual Cycle 12-14. days: ovulation phase (OP) | – | Device: Platelet rich fibrin deviceThe 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. |
| premenstrual (PmD) 22-24. days | – | Device: Platelet rich fibrin deviceThe 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich fibrin deviceWithin 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. | Device | Menstrual Cycle 1-2nd days, Menstrual Cycle 12-14. days: ovulation phase (OP), Menstrual Cycle 8-10. days : proliferative phase (PP), premenstrual (PmD) 22-24. days |
Primary outcome
Changes in EGF in the obtained PRF during the menstrual cycle
Time frame: 1 month
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). EGF levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined. At the end of the study, EGF contents of the PRF membranes obtained in different phases of MS will be compared.
Changes in IGF-1 in the obtained PRF during the menstrual cycle
Time frame: 1 month
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). IGF-1 levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined.At the end of the study, IGF-1 contents of the PRF membranes obtained in different phases of MS will be compared.
Changes in PDGF in the obtained PRF during the menstrual cycle
Time frame: 1 month
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). PDGF levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined. At the end of the study, PDGF contents of the PRF membranes obtained in different phases of MS will be compared.
Changes in TGF-beta in the obtained PRF during the menstrual cycle
Time frame: 1 month
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). TGF-beta levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined. At the end of the study, TGF-beta contents of the PRF membranes obtained in different phases of MS will be compared.
Changes in VEGF in the obtained PRF during the menstrual cycle
Time frame: 1 month
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). VEGF levels of each PRF membrane obtained at the 1st, 24th and 72nd hours will be determined. At the end of the study, VEGF contents of the PRF membranes obtained in different phases of MS will be compared.
1 secondary outcome
Change in the proportion of red blood cells and its effect on PRF.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle, run by Necmettin Erbakan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in EGF in the obtained PRF during the menstrual cycle (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.