Chemerin and IL-6 Levels in Diabetes and Periodontitis

NCT02596581 | Completed

• 1 other identifier: 2014-116-17-06
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of the present study were to determine the gingival crevicular fluid (GCF) chemerin and interleukin-6 (IL-6) levels and to analyse the relationship between chemerin and IL-6 in periodontal health and in chronic periodontitis (CP) with and without type 2 diabetes mellitus (T2DM) as well as to evaluate the effect of non-surgical periodontal therapy on the GCF chemerin levels.

Conditions

Chronic Periodontitis; Diabetes Mellitus

Keywords

periodontitis; diabetes mellitus; chemerin; interleukin-6

Outcome Measures

Primary Outcomes (1)

• gingival crevicular fluid chemerin level

  gingival crevicular fluid chemerin levels change from baseline to at 8th weeks

  8th weeks

Secondary Outcomes (5)

• Interleukin-6

  8th weeks

• gingival index

  8ths week

• plaque index

  8ths week

• bleeding on probing

  8th weeks

• clinical attachment level

  8th weeks

Study Arms (4)

diabetics with periodontally healthy group

NO INTERVENTION

Control group

systemically and periodontally healthy group

NO INTERVENTION

Control group

diabetics with chronic periodontitis group

ACTIVE COMPARATOR

non-surgical periodontal treatment was performed

Other: non-surgical periodontal treatment

chronic periodontitis group

ACTIVE COMPARATOR

non-surgical periodontal treatment was performed

Other: non-surgical periodontal treatment

Interventions

non-surgical periodontal treatment OTHER

scaling and root planing were performed

chronic periodontitis group; diabetics with chronic periodontitis group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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; Periodontitis

Condition Hierarchy (Ancestors)

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, Phd, DDS

  Bülent Ecevit University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Figen Öngöz Dede, Phd, DDS

  Bülent Ecevit University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Şeyma Bozkurt Doğan, Phd, DDS

  Bülent Ecevit University Faculty of Dentistry

  STUDY CHAIR

• Erdim Sertoğlu, MD, DDS

  Elazig Military Hospital, Department of Medical Biochemistry, Elazığ, Turke

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 4, 2015
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 4, 2015

Record last verified: 2015-11