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

Early Phase 1

Completed

• Conditions: Periodontitis; Obesity
• Interventions: Other: non surgical periodontal treatment; Other: Gingival crevicular fluid collection

• Registration Number: NCT02563171
• Lead Sponsor: Umut BALLI

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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-29
• Last Update Submitted: 2015-09-29
• Study First Posted: 2015-09-30
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic periodontitis without obesity	non surgical periodontal treatment	GCF samples were taken before and after treatment chronic periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)
Chronic periodontitis with obesity	non surgical periodontal treatment	GCF samples were taken before and after treatment chronic periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)
Healthy periodontium without obesity	Gingival crevicular fluid collection	GCF samples were taken at baseline Intervention: Gingival crevicular fluid collection
Healthy periodontium with obesity	Gingival crevicular fluid collection	GCF samples were taken at baseline Intervention: Gingival crevicular fluid collection

Primary Outcome Measures

Name	Time	Method
Biochemical parameters (Vaspin and omentin)	Baseline and 6 weeks after treatment	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.

Secondary Outcome Measures

Name	Time	Method
Clinical attachment level	Baseline and 6 weeks after treatment	The changes in clinical attachment level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.
Gingival index	Baseline and 6 weeks after treatment	The changes in gingival index after periodontal treatment. Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation. Also, gingival index was also analyzed to detect the relationship between vaspin, omentin and tumor necrosis factor alfa.
Tumor necrosis factor alfa	Baseline and 6 weeks after treatment	The changes in levels of tumor necrosis factor alfa 6 weeks after periodontal treatment determined by ELISA.
Probing pocket depth	Baseline and 6 weeks after treatment	The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.
Plaque index	Baseline and 6 weeks after treatment	The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.
Bleeding on probing	Baseline and 6 weeks after treatment	The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.