Gingival Crevicular Fluid Vaspin and Omentin Levels in Type 2 Diabetic Patients With Chronic Periodontitis

NCT02544347 | Completed

• 1 other identifier: 2014-116-17/06
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study were 1) to determine the role of these adipokines in the pathogenesis of periodontal disease, inflammation and tissue destruction comparing with gingival crevicular fluid (GCF) levels of TNF-α, which has a known pro-inflammatory effect in periodontal disease, 2) to investigate the effect of non-surgical periodontal treatment on GCF vaspin and omentin levels in type 2 diabetic (T2DM) patients with Chronic Periodontitis (CP).

Conditions

Chronic Periodontitis; Diabetes Mellitus

Keywords

vaspin; omentin; diabetes mellitus; chronic periodontitis; tumor-necrosis factor alfa; gingival crevicular fluid

Outcome Measures

Primary Outcomes (2)

• vaspin levels

  gingival crevicular fluid vaspin levels change from baseline at 8th weeks

  8th weeks

• omentin levels

  gingival crevicular fluid omentin levels change from baseline at 8th weeks

  8th weeks

Secondary Outcomes (5)

• tumor necrosis factor alfa

  8th weeks

• gingival index

  8ths week

• plaque index

  8th weeks

• bleeding on probing

  8th weeks

• clinical attachment level

  8th weeks

Study Arms (4)

diabetes mellitus group

OTHER

gingival crevicular fluid was collected

Other: gingival crevicular fluid

Control group

OTHER

gingival crevicular fluid was collected

Other: gingival crevicular fluid

diabetics with chronic periodontitis group

OTHER

non-surgical periodontal treatment was completed and gingival crevicular fluid was collected

Other: gingival crevicular fluid; Other: non-surgical periodontal treatment

chronic periodontitis group

OTHER

non-surgical periodontal treatment was completed and gingival crevicular fluid was collected

Other: gingival crevicular fluid; Other: non-surgical periodontal treatment

Interventions

gingival crevicular fluid OTHER

gingival crevicular fluid was collected

Control group; chronic periodontitis group; diabetes mellitus group; diabetics with chronic periodontitis group

non-surgical periodontal treatment OTHER

scaling and root planing were performed

chronic periodontitis group; diabetics with chronic periodontitis group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic subjects should have T2DM and had no any known systemic diseases other than T2DM
• Subjects who had HbA1c levels \< 8% and ≥ 6.5% (well and moderate control)
• Chronic periodontitis patients had radiographic evidence of bone loss and attachment loss with a minimum of 6 teeth having pocket probing depth (PD) ≥ 5mm in at least 2 different quadrants
• Control groups were designed as healthy if the full-mouth probing depth (PD) was ≤3mm and bleeding on probing (BOP) score \< %15 at examination and they had no radiographic evidence of alveolar bone loss.

You may not qualify if:

• Presence of other systemic disorders that could influence the course of periodontal disease; pregnancy, lactation, current and former use of tobacco;
• Administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months;
• Need for antibiotic prophylaxis for dental treatment and having received non-surgical periodontal treatment within the past 6 months or surgical periodontal treatment within the past 12 months.
• Subjects who had body mass index (BMI) \>24.9 kg /m2

Sponsors & Collaborators

• Bulent Ecevit University: lead

MeSH Terms

Conditions

Chronic Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Umut Ballı, DDS

  Bülent Ecevit University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Şeyma Bozkurt Doğan, DDS

  Bülent Ecevit University Faculty of Dentistry

  STUDY CHAIR

• Figen Öngöz Dede, DDS

  Bülent Ecevit University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Erdim Sertoğlu, MD, DDS

  Gülhane Military Medical Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant Proffessor, Bulent Ecevit University

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 9, 2015
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2015-09