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NCT Number: NCT02563171

Gingival Crevicular Fluid Vaspin and Omentin Levels 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non surgical periodontal treatment

Other
  • 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

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Umut BALLI

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2015
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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