Chemerin and Interleukin-6 Levels of Gingival Crevicular Fluid in Obese Individuals Following Periodontal Treatment

NCT ID: NCT02660814

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-05-31

Brief Summary

The objective in this case-control intervention study, therefore, was to explore the effect of nonsurgical periodontal therapy on the GCF levels of chemerin and IL-6 in patients with chronic periodontitis in order to determine the usefulness of chemerin as a diagnostic and prognostic biomarker of periodontal disease.

Detailed Description

All individuals underwent a full-mouth periodontal examination, which included probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on probing (BOP). BMI and WHR were used for assessing obesity. In addition, HbA1c and fasting plasma glucose levels were used for elimination of diabetes mellitus. Based on the periodontal and anthropometric measurements, individuals (n=72) were divided into four groups: the periodontal-healthy group (n=18), chronic periodontitis group (n=18), periodontal-healthy with obesity group (n=18) and chronic periodontitis with obesity group (n=18). Periodontitis patients received nonsurgical periodontal therapy. GCF sampling and clinical periodontal parameters were assessed before and 6 weeks after therapy. Chemerin and IL-6 levels were measured by enzyme-linked immunosorbent assay.

Conditions

Obesity; Periodontitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Healthy periodontium without obesity

GCF samples were taken at baseline

Intervention: Gingival crevicular fluid collection

Group Type: PLACEBO_COMPARATOR

Gingival crevicular fluid collection

Intervention Type: OTHER

GCF collection with filter paper (Periopaper) using the intracrevicular method.

Chronic periodontitis without obesity

GCF samples were taken before and after treatment chronic periodontitis patients.

Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions)

Group Type: ACTIVE_COMPARATOR

Non-surgical periodontal treatment

Intervention Type: OTHER

1. SRP under local anaesthesia, in a total of 2-3 clinical visits.

2. Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.

Gingival crevicular fluid collection

Intervention Type: OTHER

GCF collection with filter paper (Periopaper) using the intracrevicular method.

Healthy periodontium with obesity

GCF samples were taken at baseline

Intervention: Gingival crevicular fluid collection

Group Type: PLACEBO_COMPARATOR

Gingival crevicular fluid collection

Intervention Type: OTHER

GCF collection with filter paper (Periopaper) using the intracrevicular method.

Chronic periodontitis with obesity

GCF samples were taken before and after treatment chronic periodontitis patients.

Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions)

Group Type: ACTIVE_COMPARATOR

Non-surgical periodontal treatment

Intervention Type: OTHER

1. SRP under local anaesthesia, in a total of 2-3 clinical visits.

2. Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.

Gingival crevicular fluid collection

Intervention Type: OTHER

GCF collection with filter paper (Periopaper) using the intracrevicular method.

Interventions

Non-surgical periodontal treatment

1. SRP under local anaesthesia, in a total of 2-3 clinical visits.

2. Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.

Intervention Type: OTHER

Gingival crevicular fluid collection

GCF collection with filter paper (Periopaper) using the intracrevicular method.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 32-53 years of age

2. had a minimum of 20 natural teeth, excluding third molars

3) glycosylated hemoglobi levels <6%

4) fasting plasma glucose levels <100 mg/dl.

5-) Criteria for the periodontal healthy group were GI = 0, PPD≤ 3 mm, and no signs of attachment and bone loss by clinical and radiographic examination.

6-) Criteria for the chronic periodontitis group were clinical signs of inflammation (red color and swelling of the gingival margin), GI ≥ 2, PPD and CAL ≥ 5 mm, and bone loss affecting >30% of the existing teeth on clinical and radiographic examination.

7-) Criteria for obese groups were 30≤ BMI <40 kg/m2, and concomitant WHR ≥0.85 for females and WHR ≥0.90 for males.

8-) Criteria for normal-weight groups were 20≤ BMI <25 kg/m2, and WHR below that determined for obesity.

Exclusion Criteria

1. Aggressive periodontitis

2. Periapical pathologies

3. Excessive forces including mechanical forces from orthodontics and occlusion

4. Systemic diseases (e.g., diabetes mellitus; cancer; human immunodeficiency virus; or disorders that could affect adipokines levels and the periodontal conditions)

5. Chronic high-dose steroid therapy, radiation or immunosuppressive therapy

6. Pregnancy, lactation

7. Smoking within the past five years, or allergy or sensitivity to any drug

8. Had no history of periodontal therapy or drug therapy (e.g., anti-inflammatories, antibiotics, or any other pharmacological treatment) for at least six months

• Minimum Eligible Age: 32 Years
• Maximum Eligible Age: 53 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Umut BALLI

OTHER

Sponsor Role: lead

Responsible Party

Umut BALLI

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2014-115-17/06.

Identifier Type: -

Identifier Source: org_study_id