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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563171
• Other study ID #: 2014-115-17/06
• Status: Completed
• Phase: Phase 0
• First received: September 28, 2015
• Last updated: September 29, 2015
• Start date: July 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 49 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Obesity
• Periodontitis

Intervention

Other:
• non surgical periodontal treatment
SRP under local anaesthesia, in a total of 2-3 clinical visits. Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.
• Gingival crevicular fluid collection
GCF collection with filter paper (Periopaper) using the intracrevicular method.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Umut BALLI

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Tumor necrosis factor alfa	The changes in levels of tumor necrosis factor alfa 6 weeks after periodontal treatment determined by ELISA.	Baseline and 6 weeks after treatment	No
Secondary	Probing pocket depth	The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.	Baseline and 6 weeks after treatment	No
Secondary	Clinical attachment level	The changes in clinical attachment level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.	Baseline and 6 weeks after treatment	No
Secondary	Gingival index	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.	Baseline and 6 weeks after treatment	No
Secondary	Plaque index	The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.	Baseline and 6 weeks after treatment	No
Secondary	Bleeding on probing	The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.	Baseline and 6 weeks after treatment	No