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PRF Growth Factors Levels in Diabetic Patients With Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02304497
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Seyma Bozkurt Doğan, Bulent Ecevit University

Brief 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. 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.

Condition or disease Intervention/treatment
Diabetes Mellitus Chronic Periodontitis Other: Platelet Rich Fibrin

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Evaluation of Platelet Rich Fibrin Growth Factors (PRF) in Type 2 Diabetic Patients With Chronic Periodontitis
Study Start Date : March 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : November 2014

Group/Cohort Intervention/treatment
DM-CTRL
Diabetes mellitus patients with periodontally healthy Platelet Rich Fibrin obtained
Other: Platelet Rich Fibrin
Procedure: Platelet Rich Fibrin obtained

DM-CP
Diabetes mellitus patients with chronic periodontitis Platelet Rich Fibrin obtained
Other: Platelet Rich Fibrin
Procedure: Platelet Rich Fibrin obtained

CP
Chronic periodontitis patients with systemically healthy Platelet Rich Fibrin obtained
Other: Platelet Rich Fibrin
Procedure: Platelet Rich Fibrin obtained

CTRL
Periodontally and systemically healthy subject Platelet Rich Fibrin obtained
Other: Platelet Rich Fibrin
Procedure: Platelet Rich Fibrin obtained




Primary Outcome Measures :
  1. Platelet Rich Fibrin (PRF) levels of vascular endothelial growth factor (VEGF) [ Time Frame: Baseline ]
  2. PRF levels of platelet derived growth factor- AB (PDGF-AB) [ Time Frame: Baseline ]
  3. PRF levels of basic- fibroblast growth factor (b-FGF) [ Time Frame: Baseline ]
  4. PRF levels of transforming growth factor- beta 1 (TGF-β1) [ Time Frame: Baseline ]
  5. PRF levels of transforming growth factor- beta 2 (TGF-β2) [ Time Frame: Baseline ]
  6. PRF levels of insulin like growth factor -1 (IGF-1) [ Time Frame: Baseline ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304497


Sponsors and Collaborators
Bulent Ecevit University
Investigators
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Study Chair: Şeyma Bozkurt Doğan, DDS Bülent Ecevit University Faculty of Dentistry
Principal Investigator: Umut Ballı, DDS Bülent Ecevit University Faculty of Dentistry
Study Director: Figen Öngöz Dede, DDS Bülent Ecevit University Faculty of Dentistry
Principal Investigator: Mustafa Cenk Durmuşlar, DDS Bülent Ecevit University Faculty of Dentistry
Principal Investigator: Murat Can, Assoc. Professor Bülent Ecevit University Faculty of Medicine

Additional Information:

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Responsible Party: Seyma Bozkurt Doğan, PhD, DDS, Bulent Ecevit University
ClinicalTrials.gov Identifier: NCT02304497     History of Changes
Other Study ID Numbers: 2013-62550515-01
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Seyma Bozkurt Doğan, Bulent Ecevit University:
Diabetes mellitus
Platelet rich fibrin
growth factor

Additional relevant MeSH terms:
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Chronic Periodontitis
Diabetes Mellitus
Periodontitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action