Gingival Crevicular Fluid Vaspin and Omentin Levels in Obese Patients With Chronic Periodontitis

NCT02563171 | Completed Early Phase 1

• 1 other identifier: 2014-115-17/06
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity; Periodontitis

Keywords

visceral adipose-specific serpin; intelectin 1 (omentin); Tumor Necrosis Factor-alpha

Outcome Measures

Primary Outcomes (1)

• Biochemical parameters (Vaspin and omentin)

  The changes in levels of vaspin and omentin 6 weeks after periodontal treatment determined by ELISA. The changes in levels of vaspin and omentin were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontal disease.

  Baseline and 6 weeks after treatment

Secondary Outcomes (6)

• Tumor necrosis factor alfa

  Baseline and 6 weeks after treatment

• 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

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

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

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.

Healthy periodontium with obesity; Healthy periodontium without obesity

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ) 30-49 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.
• ) 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Bulent Ecevit University

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 30, 2015
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 30, 2015

Record last verified: 2015-09