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

NCT02660814 | Completed Early Phase 1

• 1 other identifier: 2014-115-17/06.
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Periodontitis

Keywords

Chemerin; Interleukin-6; Gingival crevicular fluid

Outcome Measures

Primary Outcomes (1)

• Chemerin

  The changes in levels of chemerin 6 weeks after periodontal treatment determined by ELISA.

  Baseline and 6 weeks after treatment

Secondary Outcomes (6)

• Probing pocket depth

  Baseline and 6 weeks after treatment

• Clinical attachment level

  Baseline and 6 weeks after treatment

• Gingival index

  Baseline and 6 weeks after treatment

• Plaque index

  Baseline and 6 weeks after treatment

• Bleeding on probing

  Baseline and 6 weeks after treatment

Study Arms (4)

Healthy periodontium without obesity

PLACEBO COMPARATOR

GCF samples were taken at baseline Intervention: Gingival crevicular fluid collection

Other: Gingival crevicular fluid collection

Chronic periodontitis without obesity

ACTIVE COMPARATOR

GCF samples were taken before and after treatment chronic periodontitis patients. Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions)

Other: Non-surgical periodontal treatment; Other: Gingival crevicular fluid collection

Healthy periodontium with obesity

PLACEBO COMPARATOR

GCF samples were taken at baseline Intervention: Gingival crevicular fluid collection

Other: Gingival crevicular fluid collection

Chronic periodontitis with obesity

ACTIVE COMPARATOR

GCF samples were taken before and after treatment chronic periodontitis patients. Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions)

Other: Non-surgical periodontal treatment; Other: Gingival crevicular fluid collection

Interventions

Non-surgical periodontal treatment 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.

Chronic periodontitis with obesity; Chronic periodontitis without obesity

Gingival crevicular fluid collection OTHER

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

Chronic periodontitis with obesity; Chronic periodontitis without obesity; Healthy periodontium with obesity; Healthy periodontium without obesity

Eligibility Criteria

• Age: 32 Years - 53 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• had a minimum of 20 natural teeth, excluding third molars
• \) glycosylated hemoglobi levels \<6%
• \) fasting plasma glucose levels \<100 mg/dl.
• ) 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.
• ) 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.
• ) Criteria for obese groups were 30≤ BMI \<40 kg/m2, and concomitant WHR ≥0.85 for females and WHR ≥0.90 for males.
• ) Criteria for normal-weight groups were 20≤ BMI \<25 kg/m2, and WHR below that determined for obesity.

You may not qualify if:

• Aggressive periodontitis
• Periapical pathologies
• Excessive forces including mechanical forces from orthodontics and occlusion
• Systemic diseases (e.g., diabetes mellitus; cancer; human immunodeficiency virus; or disorders that could affect adipokines levels and the periodontal conditions)
• Chronic high-dose steroid therapy, radiation or immunosuppressive therapy
• Pregnancy, lactation
• Smoking within the past five years, or allergy or sensitivity to any drug
• Had no history of periodontal therapy or drug therapy (e.g., anti-inflammatories, antibiotics, or any other pharmacological treatment) for at least six months

Sponsors & Collaborators

• Umut BALLI: lead

MeSH Terms

Conditions

Obesity; Periodontitis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 21, 2016
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 22, 2016

Record last verified: 2016-01