Diabetes MellitusNCT02304497
PRF Growth Factors Levels in Diabetic Patients With Chronic Periodontitis
An observational study of Diabetes Mellitus and Chronic Periodontitis, run by Bulent Ecevit University.
Trial summary
Diabetic patients may show different release of growth factors when microvascular complications such as; retinopathy or periodontitis are seen. Diabetes have an adverse effect on periodontal health and periodontal infection have an adverse effect on glycemic control and incidence of diabetes complications. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Chronic Periodontitis
- What is being tested?
- Platelet Rich Fibrin
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Nov 2014
- How long will I take part?
- 1 Day
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients participating the study were recruited from indivuduals referred to Department of Periodontology, Faculty of Dentistry, University of Bülent Ecevit University for either dental treatment or dental check-ups.
Who may be able to join
- CP patients required a diagnosis of moderate to advanced CP and showing radiographic evidence of bone loss and, defined as clinical attachment loss with a minimum of 6 teeth having periodontal pocket greater than 4 mm, a minimum of 20 natural teeth,
- No periodontal treatment in the prior 6 months.
- T2DM patients who had HbA1c levels between 6%-8 %
- Periodontally healthy subjects (periodontal pocket depth < 4 mm)
Who cannot join
- If they had any known systemic diseases other than type 2 diabetes mellitus
- Patient had been under medicine treatment for at least 6 months except patients with diabetes who were treated with stable doses of hypoglycemic agents
- Patients with major complications of DM (i.e., cardiovascular and peripheral vascular diseases
- Insufficient platelet count (<200,000/mm3); 2) pregnancy/lactation )
- Tobacco use
- Pregnancy
About this study
Official title: Evaluation of Platelet Rich Fibrin Growth Factors (PRF) in Type 2 Diabetic Patients With Chronic Periodontitis
Diabetic patients may show different release of growth factors when microvascular complications such as; retinopathy or periodontitis are seen. Diabetes have an adverse effect on periodontal health and periodontal infection have an adverse effect on glycemic control and incidence of diabetes complications. Therefore, the investigators hypothesize that growth factors levels releasing from platelet rich fibrin (PRF) in diabetes mellitus (DM) may be decrease because of periodontitis is considered to be the sixth microvascular complication of diabetes or diabetes may have inductive effect on PRF growth factors levels in periodontal disease. Determination of PRF growth factors levels may be beneficial to treatment of diabetic patient with periodontal disease by using PRF.
Read the detailed description
The aim of the investigators study was to evaluate levels of platelet derived growth factor-AB (PDGF-AB), vascular endothelial growth factor ( VEGF),transforming growth factor-beta1 and beta 2 (TGF-β1 and β2), basic-Fibroblast growth factor (b-FGF), insulin like growth factor-1 ( IGF-1) in type 2 diabetic (T2DM) patients with chronic periodontitis.
This study consisted of 80 subjects; 20 patients were T2DM with periodontally healthy (DM-CTRL), 20 patients were T2DM with chronic periodontitis (DM-CP ), 20 patients were systemically healthy with chronic periodontitis (CP; ), 20 subjects were systemically and periodontally healthy (CTRL).
Subjects were clinically evaluated with regards to the plaque index (PI), gingival index (GI), probing pockets depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) recorded at six sites per tooth (disto-facial, mid-facial, mesio-facial, mesio-lingual, disto-lingual and mid-lingual) using a periodontal Goldman/Fox Williams probe calibrated in millimeters.
PRF was prepared without biochemical manipulation of blood. Intravenous blood from each patient was collected in 10 ml sterile tubes without anticoagulant by venipuncture of antecubital vein. Immediately test tubes were centrifuged using a centrifugation machine ( Electro.mag M 815 P Laboratory Centrifuge ; Istanbul, Turkey) at 2700 rpm ( approximately 700g ) for 12 min . The centrifuged blood presented with a structured fibrin clot in the middle of the tube just between the red corpuscles at the bottom and acellular plasma at the top. PRF was easily separated from the red corpuscule base using steril scissors and inserted into steril tubes. The tubes were put on a shaker and agitated gently. After 5 minutes, the tubes were vortexed to form a PRF membrane and the volume of releasate was measured and the releasate returned into the tube. The tubes were further agitated gently. Samples were taken at 5th minute and immediately centrifuged at 5000rpm for 15 minutes (Electro.mag M 815 P Laboratory Centrifuge ; Istanbul, Turkey) to pellet any residual blood cells , and were stored at -80 centigrade degree for subsequent assays.
Samples were assayed by using enzyme-linked immunosorbent assay (ELISA) with an ELX 800 G ELISA device (BIO-TEC Instruments, Winooski, USA). The following ELISA kits were used in this study: b-FGF, TGF-β2 and IGF 1 (Assay Biotechnology Company, CA, USA); PDGF-AB, VEGF and TGF-β1 (Boster Biological Technology, CA, USA).
Statistical analysis was performed using a commercially available software (SPSS 15.0; SPSS Inc., Chicago, IL). The Shapiro-Wilk test was used to investigate whether the data were normally distributed. When normal distribution with equal variances was assumed in PDGF-AB, VEGF, TGF-β1, variables were compared using one-way analysis of variance (ANOVA) with Bonferroni post hoc test. If the assumption of normality failed, comparisons of the age, TGF-β2, b-FGF, IGF-1, HbA1c, fasting blood glucose, postprandial blood glucose, full-mouth PD, CAL, GI, PI and BOP were tested using the Kruskal-Wallis non-parametric test followed by post-hoc group comparisons with the Bonferroni-adjusted Mann-Whitney U test.
- Conditions
- Diabetes Mellitus, Chronic Periodontitis
- Being tested
- Platelet Rich Fibrin
- Keywords
- Diabetes mellitus, Platelet rich fibrin, growth factor
- Medical subject headings
- Diabetes Mellitus, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich FibrinOther
Procedure: Platelet Rich Fibrin obtained
| Study group | Role | What they receive |
|---|---|---|
| DM-CTRL | Diabetes mellitus patients with periodontally healthy Platelet Rich Fibrin obtained Receives: Other: Platelet Rich Fibrin | |
| DM-CP | Diabetes mellitus patients with chronic periodontitis Platelet Rich Fibrin obtained Receives: Other: Platelet Rich Fibrin | |
| CP | Chronic periodontitis patients with systemically healthy Platelet Rich Fibrin obtained Receives: Other: Platelet Rich Fibrin | |
| CTRL | Periodontally and systemically healthy subject Platelet Rich Fibrin obtained Receives: Other: Platelet Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Rich Fibrin (PRF) levels of vascular endothelial growth factor (VEGF)
Measured: Baseline
PRF levels of platelet derived growth factor- AB (PDGF-AB)
Measured: Baseline
PRF levels of basic- fibroblast growth factor (b-FGF)
Measured: Baseline
PRF levels of transforming growth factor- beta 1 (TGF-β1)
Measured: Baseline
PRF levels of transforming growth factor- beta 2 (TGF-β2)
Measured: Baseline
PRF levels of insulin like growth factor -1 (IGF-1)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startMar 2013
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Bozkurt Doğan, Bulent Ecevit University
- Investigators
- Şeyma Bozkurt Doğan, DDS, Study chair, Bülent Ecevit University Faculty of DentistryUmut Ballı, DDS, Principal investigator, Bülent Ecevit University Faculty of DentistryFigen Öngöz Dede, DDS, Study director, Bülent Ecevit University Faculty of DentistryMustafa Cenk Durmuşlar, DDS, Principal investigator, Bülent Ecevit University Faculty of DentistryMurat Can, Assoc. Professor, Principal investigator, Bülent Ecevit University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304497
- Sponsor's protocol ID
- 2013-62550515-01
- Status last verified
- Dec 2014
- First submitted
- 21 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet Rich Fibrin Growth Factors (PRF) in Type 2 Diabetic Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT02304497
- Acronym / sponsor ID
- 2013-62550515-01
- Conditions
- Diabetes Mellitus, Chronic Periodontitis
- Keywords
- Diabetes mellitus, Platelet rich fibrin, growth factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Dec 2014 (estimated)
- 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.
Diabetic patients may show different release of growth factors when microvascular complications such as; retinopathy or periodontitis are seen. Diabetes have an adverse effect on periodontal health and periodontal infection have an adverse effect on glycemic control and incidence of diabetes complications. Therefore, the investigators hypothesize that growth factors levels releasing from platelet rich fibrin (PRF) in diabetes mellitus (DM) may be decrease because of periodontitis is considered to be the sixth microvascular complication of diabetes or diabetes may have inductive effect on PRF growth factors levels in periodontal disease. Determination of PRF growth factors levels may be beneficial to treatment of diabetic patient with periodontal disease by using PRF.
Detailed description
The aim of the investigators study was to evaluate levels of platelet derived growth factor-AB (PDGF-AB), vascular endothelial growth factor ( VEGF),transforming growth factor-beta1 and beta 2 (TGF-β1 and β2), basic-Fibroblast growth factor (b-FGF), insulin like growth factor-1 ( IGF-1) in type 2 diabetic (T2DM) patients with chronic periodontitis.
This study consisted of 80 subjects; 20 patients were T2DM with periodontally healthy (DM-CTRL), 20 patients were T2DM with chronic periodontitis (DM-CP ), 20 patients were systemically healthy with chronic periodontitis (CP; ), 20 subjects were systemically and periodontally healthy (CTRL).
Subjects were clinically evaluated with regards to the plaque index (PI), gingival index (GI), probing pockets depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) recorded at six sites per tooth (disto-facial, mid-facial, mesio-facial, mesio-lingual, disto-lingual and mid-lingual) using a periodontal Goldman/Fox Williams probe calibrated in millimeters.
PRF was prepared without biochemical manipulation of blood. Intravenous blood from each patient was collected in 10 ml sterile tubes without anticoagulant by venipuncture of antecubital vein. Immediately test tubes were centrifuged using a centrifugation machine ( Electro.mag M 815 P Laboratory Centrifuge ; Istanbul, Turkey) at 2700 rpm ( approximately 700g ) for 12 min . The centrifuged blood presented with a structured fibrin clot in the middle of the tube just between the red corpuscles at the bottom and acellular plasma at the top. PRF was easily separated from the red corpuscule base using steril scissors and inserted into steril tubes. The tubes were put on a shaker and agitated gently. After 5 minutes, the tubes were vortexed to form a PRF membrane and the volume of releasate was measured and the releasate returned into the tube. The tubes were further agitated gently. Samples were taken at 5th minute and immediately centrifuged at 5000rpm for 15 minutes (Electro.mag M 815 P Laboratory Centrifuge ; Istanbul, Turkey) to pellet any residual blood cells , and were stored at -80 centigrade degree for subsequent assays.
Samples were assayed by using enzyme-linked immunosorbent assay (ELISA) with an ELX 800 G ELISA device (BIO-TEC Instruments, Winooski, USA). The following ELISA kits were used in this study: b-FGF, TGF-β2 and IGF 1 (Assay Biotechnology Company, CA, USA); PDGF-AB, VEGF and TGF-β1 (Boster Biological Technology, CA, USA).
Statistical analysis was performed using a commercially available software (SPSS 15.0; SPSS Inc., Chicago, IL). The Shapiro-Wilk test was used to investigate whether the data were normally distributed. When normal distribution with equal variances was assumed in PDGF-AB, VEGF, TGF-β1, variables were compared using one-way analysis of variance (ANOVA) with Bonferroni post hoc test. If the assumption of normality failed, comparisons of the age, TGF-β2, b-FGF, IGF-1, HbA1c, fasting blood glucose, postprandial blood glucose, full-mouth PD, CAL, GI, PI and BOP were tested using the Kruskal-Wallis non-parametric test followed by post-hoc group comparisons with the Bonferroni-adjusted Mann-Whitney U test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DM-CTRL | – | Other: Platelet Rich FibrinDiabetes mellitus patients with periodontally healthy Platelet Rich Fibrin obtained |
| DM-CP | – | Other: Platelet Rich FibrinDiabetes mellitus patients with chronic periodontitis Platelet Rich Fibrin obtained |
| CP | – | Other: Platelet Rich FibrinChronic periodontitis patients with systemically healthy Platelet Rich Fibrin obtained |
| CTRL | – | Other: Platelet Rich FibrinPeriodontally and systemically healthy subject Platelet Rich Fibrin obtained |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients participating the study were recruited from indivuduals referred to Department of Periodontology, Faculty of Dentistry, University of Bülent Ecevit University for either dental treatment or dental check-ups.
Key inclusion criteria (4 listed)
- CP patients required a diagnosis of moderate to advanced CP and showing radiographic evidence of bone loss and, defined as clinical attachment loss with a minimum of 6 teeth having periodontal pocket greater than 4 mm, a minimum of 20 natural teeth,
- No periodontal treatment in the prior 6 months.
- T2DM patients who had HbA1c levels between 6%-8 %
- Periodontally healthy subjects (periodontal pocket depth < 4 mm)
Key exclusion criteria (6 listed)
- If they had any known systemic diseases other than type 2 diabetes mellitus
- Patient had been under medicine treatment for at least 6 months except patients with diabetes who were treated with stable doses of hypoglycemic agents
- Patients with major complications of DM (i.e., cardiovascular and peripheral vascular diseases
- Insufficient platelet count (<200,000/mm3); 2) pregnancy/lactation )
- Tobacco use
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 FibrinProcedure: Platelet Rich Fibrin obtained | Other | CP, CTRL, DM-CP, DM-CTRL |
Primary outcome
Platelet Rich Fibrin (PRF) levels of vascular endothelial growth factor (VEGF)
Time frame: Baseline
PRF levels of platelet derived growth factor- AB (PDGF-AB)
Time frame: Baseline
PRF levels of basic- fibroblast growth factor (b-FGF)
Time frame: Baseline
PRF levels of transforming growth factor- beta 1 (TGF-β1)
Time frame: Baseline
PRF levels of transforming growth factor- beta 2 (TGF-β2)
Time frame: Baseline
PRF levels of insulin like growth factor -1 (IGF-1)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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.
Şeyma Bozkurt Doğan, DDS study chair
Bülent Ecevit University Faculty of Dentistry
Umut Ballı, DDS principal investigator
Bülent Ecevit University Faculty of Dentistry
Figen Öngöz Dede, DDS study director
Bülent Ecevit University Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Chronic Periodontitis, run by Bulent Ecevit 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 2 Dec 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Platelet Rich Fibrin (PRF) levels of vascular endothelial growth factor (VEGF) (time frame: Baseline). The study lists 6 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 2 Dec 2014.