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

Primary Purpose

Obesity, Periodontitis

Status

Completed

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

non surgical periodontal treatment

Gingival crevicular fluid collection

About this trial

This is an interventional treatment trial for Obesity focused on measuring visceral adipose-specific serpin, intelectin 1 (omentin), Tumor Necrosis Factor-alpha

Eligibility Criteria

30 Years - 49 Years (Adult)All SexesAccepts 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:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Healthy periodontium without obesity

Chronic periodontitis without obesity

Healthy periodontium with obesity

Chronic periodontitis with obesity

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tumor necrosis factor alfa

The changes in levels of tumor necrosis factor alfa 6 weeks after periodontal treatment determined by ELISA.

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.

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.

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.

Plaque index

The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.

Bleeding on probing

The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.

Full Information

NCT ID

NCT02563171

First Posted

September 28, 2015

Last Updated

September 29, 2015

Sponsor

Umut BALLI

1. Study Identification

Unique Protocol Identification Number

NCT02563171

Brief Title

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

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Umut BALLI

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Periodontitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy periodontium without obesity

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Chronic periodontitis without obesity

Arm Type

Active Comparator

Arm Description

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

Arm Title

Healthy periodontium with obesity

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Chronic periodontitis with obesity

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

non surgical periodontal treatment

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Gingival crevicular fluid collection

Intervention Description

GCF collection with filter paper (Periopaper) using the intracrevicular method.

Primary Outcome Measure Information:

Title

Biochemical parameters (Vaspin and omentin)

Description

Time Frame

Baseline and 6 weeks after treatment

Secondary Outcome Measure Information:

Title

Tumor necrosis factor alfa

Description

The changes in levels of tumor necrosis factor alfa 6 weeks after periodontal treatment determined by ELISA.

Time Frame

Baseline and 6 weeks after treatment

Title

Probing pocket depth

Description

The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.

Time Frame

Baseline and 6 weeks after treatment

Title

Clinical attachment level

Description

The changes in clinical attachment level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.

Time Frame

Baseline and 6 weeks after treatment

Title

Gingival index

Description

Time Frame

Baseline and 6 weeks after treatment

Title

Plaque index

Description

The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.

Time Frame

Baseline and 6 weeks after treatment

Title

Bleeding on probing

Description

The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.

Time Frame

Baseline and 6 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

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: 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.

12. IPD Sharing Statement

Learn more about this trial

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

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