PRF Growth Factors Levels in Diabetic Patients With Chronic Periodontitis

NCT02304497 | Completed

• 1 other identifier: 2013-62550515-01
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Chronic Periodontitis

Keywords

Diabetes mellitus; Platelet rich fibrin; growth factor

Outcome Measures

Primary Outcomes (6)

• Platelet Rich Fibrin (PRF) levels of vascular endothelial growth factor (VEGF)

  Baseline

• PRF levels of platelet derived growth factor- AB (PDGF-AB)

  Baseline

• PRF levels of basic- fibroblast growth factor (b-FGF)

  Baseline

• PRF levels of transforming growth factor- beta 1 (TGF-β1)

  Baseline

• PRF levels of transforming growth factor- beta 2 (TGF-β2)

  Baseline

• PRF levels of insulin like growth factor -1 (IGF-1)

  Baseline

Study Arms (4)

DM-CTRL

Diabetes mellitus patients with periodontally healthy Platelet Rich Fibrin obtained

Other: Platelet Rich Fibrin

DM-CP

Diabetes mellitus patients with chronic periodontitis Platelet Rich Fibrin obtained

Other: Platelet Rich Fibrin

CP

Chronic periodontitis patients with systemically healthy Platelet Rich Fibrin obtained

Other: Platelet Rich Fibrin

CTRL

Periodontally and systemically healthy subject Platelet Rich Fibrin obtained

Other: Platelet Rich Fibrin

Interventions

Platelet Rich Fibrin OTHER

Procedure: Platelet Rich Fibrin obtained

CP; CTRL; DM-CP; DM-CTRL

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bulent Ecevit University: lead

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Şeyma Bozkurt Doğan, DDS

  Bülent Ecevit University Faculty of Dentistry

  STUDY CHAIR

• Umut Ballı, DDS

  Bülent Ecevit University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Figen Öngöz Dede, DDS

  Bülent Ecevit University Faculty of Dentistry

  STUDY DIRECTOR

• Mustafa Cenk Durmuşlar, DDS

  Bülent Ecevit University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Murat Can, Assoc. Professor

  Bülent Ecevit University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, DDS

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 2, 2014
• Study Start: March 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12