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

Umut BALLI

Status and phase: Completed; Early Phase 1

Conditions: Periodontitis; Obesity

Treatments: Other: Gingival crevicular fluid collection; Other: non surgical periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02563171

2014-115-17/06

Details and patient eligibility

About

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.

Full 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=76) were divided into four groups: the periodontal-healthy group (n=19), chronic periodontitis group (n=19), periodontal-healthy with obesity group (n=19) and chronic periodontitis with obesity group (n=19). Periodontitis patients received nonsurgical periodontal therapy. GCF sampling and clinical periodontal parameters were assessed before and 6 weeks after therapy. Vaspin, omentin, and TNF-α levels were measured by enzyme-linked immunosorbent assay.

Enrollment: 76 patients

Sex: All

Ages: 30 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1-) 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 4 patient groups, including a placebo group

Healthy periodontium without obesity

Placebo Comparator group

Description:

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

Treatment:

Other: Gingival crevicular fluid collection

Chronic periodontitis without obesity

Active Comparator group

Description:

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

Treatment:

Other: non surgical periodontal treatment

Healthy periodontium with obesity

Placebo Comparator group

Description:

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

Treatment:

Other: Gingival crevicular fluid collection

Chronic periodontitis with obesity

Active Comparator group

Description:

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

Treatment:

Other: non surgical periodontal treatment