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

September 29, 2015 updated by: Umut BALLI

Effects of Non-Surgical Periodontal Treatment on the Gingival Crevicular Fluid Levels of Vaspin and Omentin-1 in Obese Patients With Chronic Periodontitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Healthy periodontium without obesity
GCF samples were taken at baseline Intervention: Gingival crevicular fluid collection
Other: Gingival crevicular fluid collection
GCF collection with filter paper (Periopaper) using the intracrevicular method.
Active Comparator: Chronic periodontitis without obesity

GCF samples were taken before and after treatment chronic periodontitis patients.

Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)
Other: non surgical periodontal treatment
  1. SRP under local anaesthesia, in a total of 2-3 clinical visits.
  2. Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.
Placebo Comparator: Healthy periodontium with obesity
GCF samples were taken at baseline Intervention: Gingival crevicular fluid collection
Other: Gingival crevicular fluid collection
GCF collection with filter paper (Periopaper) using the intracrevicular method.
Active Comparator: Chronic periodontitis with obesity

GCF samples were taken before and after treatment chronic periodontitis patients.

Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)
Other: non surgical periodontal treatment
  1. SRP under local anaesthesia, in a total of 2-3 clinical visits.
  2. Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical parameters (Vaspin and omentin)
Time Frame: 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.
Baseline and 6 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor necrosis factor alfa
Time Frame: Baseline and 6 weeks after treatment
The changes in levels of tumor necrosis factor alfa 6 weeks after periodontal treatment determined by ELISA.
Baseline and 6 weeks after treatment
Probing pocket depth
Time Frame: 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.
Baseline and 6 weeks after treatment
Clinical attachment level
Time Frame: 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.
Baseline and 6 weeks after treatment
Gingival index
Time Frame: 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.
Baseline and 6 weeks after treatment
Plaque index
Time Frame: 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.
Baseline and 6 weeks after treatment
Bleeding on probing
Time Frame: 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.
Baseline and 6 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umut BALLI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-115-17/06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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