Clinical trial NCT02563171: Gingival Crevicular Fluid Vaspin and Omentin Levels in Obese Patients With Chronic Periodontitis
Official title: Effects of Non-Surgical Periodontal Treatment on the Gingival Crevicular Fluid Levels of Vaspin and Omentin-1 in Obese Patients With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Periodontitis
Keywords: visceral adipose-specific serpin
intelectin 1 (omentin)
Tumor Necrosis Factor-alpha
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 76
Sex: ALL
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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=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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biochemical parameters (Vaspin and omentin)
timeFrame: Baseline and 6 weeks after treatment
Secondary outcomes:
measure: Tumor necrosis factor alfa
timeFrame: Baseline and 6 weeks after treatment
measure: Probing pocket depth
timeFrame: Baseline and 6 weeks after treatment
measure: Clinical attachment level
timeFrame: Baseline and 6 weeks after treatment
measure: Gingival index
timeFrame: Baseline and 6 weeks after treatment
measure: Plaque index
timeFrame: Baseline and 6 weeks after treatment
measure: Bleeding on probing
timeFrame: Baseline and 6 weeks after treatment
Other outcomes:
Locations:
Study officials:
References: