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The Effects of Obesity on Glutathione Levels in Patients With Chronic Periodontitis Before and After Periodontal Therapy

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
nonsurgical periodontal therapy
oral hygiene instructions
nonsurgical periodontal therapy
oral hygiene instructions
Sponsored by
Figen ÖNGÖZ DEDE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • never-smokers
  • no history of systemic disease
  • no patients had been under periodontal therapy and medicine for at least 6 months before the study
  • no pregnancy or lactation
  • no alcohol or antioxidant vitamin consumption.

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Placebo Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    obese-chronic periodontitis patients

    obese-periodontally healthy controls

    normal weight-CP patients

    normal weight-PH controls

    Arm Description

    GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy

    GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions

    GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy

    GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions

    Outcomes

    Primary Outcome Measures

    Biochemical parameters (GSH and GSSG levels, GSH/GSSG ratio )
    The changes in levels of reduced and oxidized glutathione (GSH and GSSG) 1 month after periodontal treatment determined by ELISA. The changes in levels of GSH were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontitis and obesity.

    Secondary Outcome Measures

    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.
    Probing pocket depth and clinical attachment level
    The changes in clinical attachment level after periodontal treatment. The probing depth and the distance from the gingival margin to the cemento-enamel junction are used to measurement of clinical attachment level. Clinical attachment level was measured for determining severity of disease and clinic outcome.
    Gingival index
    he changes in gingival index after periodontal treatment. Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation.
    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

    First Posted
    July 9, 2015
    Last Updated
    July 14, 2015
    Sponsor
    Figen ÖNGÖZ DEDE
    Collaborators
    Bulent Ecevit University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02498561
    Brief Title
    The Effects of Obesity on Glutathione Levels in Patients With Chronic Periodontitis Before and After Periodontal Therapy
    Official Title
    Phase 1 Study of Periodontal Disease and Obese Individuals That Investigate of Local and Systemic Antioxidant Levels of Before and After Periodontal Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Figen ÖNGÖZ DEDE
    Collaborators
    Bulent Ecevit University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Obesity may affect periodontal health by inducing gingival oxidative damage through increased production in circulating reactive oxygen species (ROS). Previous studies have reported decreased glutathione levels in patients with periodontitis when compared to healthy subjects in gingival crevicular fluid (GCF), plasma and saliva. In the present study we hypothesized that high ROS levels in circulation may decrease glutathione levels in the GCF,plasma and saliva in obese patients with chronic periodontitis, whereas periodontal therapy could have positive effects on glutathione levels.
    Detailed Description
    The purpose of this study was to investigate the effects of obesity on glutathione levels in the plasma, GCF and saliva of patients with chronic periodontitis and to evaluate changes after nonsurgical periodontal therapy. Diagnosed as obese (n=30) and normal-weight (n=30) individuals were categorized; chronic periodontitis (CP) and periodontally healthy controls (PH). Gingival crevicular fluid (GCF), plasma, saliva samples and clinical measurements were obtained at baseline and a month after nonsurgical periodontal therapy. Unstimulated salivary samples were collected using standard techniques. About 2 mL whole saliva was collected in disposable tubes and centrifuged immediately to remove cell debris (10,000 g x 10 minutes). The supernatants (50µL each) were stored at -40C until analyzed. GCF samples were collected from a mesio-buccal and disto-palatal site on each tooth. In the CP group, the samples were obtained from patients at areas with ≥5 mm CAL, ≥6 mm PD and ≥30% bone loss. In gingivitis group, GCF samples were obtained from teeth with BOP and without CAL. In the healthy group, GCF samples were collected from teeth exhibiting PD<3 mm without CAL and BOP. The area was isolated with cotton rolls, saliva contamination elimination was ensured, and it was slightly air dried. GCF was sampled with paper strips. Paper strips were placed into the crevice until mild resistance was felt (intracrevicular method) and left in the position for 30 seconds. Strips contaminated with blood or saliva were discarded. Each sampled strip was placed into a 400µl eppendorf centrifuge tube and stored at -40C until analyzed. Five milliliters of venous blood was taken from antecubital vein by using a standard venipuncture method. Obtained blood sample was collected in vacutainer tubes and anti-coagulated with EDTA. The blood samples were then stored at -40C until required for use in ELISAs. Power analysis indicated that 12 individuals for each group would be sufficient to achieve 80% power to detect a difference of 0.05 between the alternative and the null hypotheses. The Shapiro Wilk test was used to investigate whether or not the data were normally distributed. Continuous variables with unequal variances were compared by means of Welch and Tamhane's T2 post-hoc test for BMI, PD, CAL and the levels of glutathione. The comparison of the age, GI, PI and BOP was analyzed using the Kruskal-Wallis non-parametric test followed by post hoc group comparisons with the Bonferroni-adjusted Mann-Whitney U test. Paired Student's t-test or Wilcoxon rank-sum test was used to compare the measurements at two points (baseline and after SRP). The Spearman's rank correlation test was also used to detect the relationship between biochemical and clinical findings.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    obese-chronic periodontitis patients
    Arm Type
    Active Comparator
    Arm Description
    GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy
    Arm Title
    obese-periodontally healthy controls
    Arm Type
    Placebo Comparator
    Arm Description
    GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions
    Arm Title
    normal weight-CP patients
    Arm Type
    Active Comparator
    Arm Description
    GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy
    Arm Title
    normal weight-PH controls
    Arm Type
    Placebo Comparator
    Arm Description
    GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions
    Intervention Type
    Procedure
    Intervention Name(s)
    nonsurgical periodontal therapy
    Other Intervention Name(s)
    obese-chronic periodontitis patients
    Intervention Description
    Scaling and root planning under local anaesthesia, in a total of four 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
    Procedure
    Intervention Name(s)
    oral hygiene instructions
    Other Intervention Name(s)
    obese-periodontally healthy controls
    Intervention Description
    Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush
    Intervention Type
    Procedure
    Intervention Name(s)
    nonsurgical periodontal therapy
    Other Intervention Name(s)
    normal weight-CP patients
    Intervention Description
    Scaling and root planning under local anaesthesia, in a total of four 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
    Procedure
    Intervention Name(s)
    oral hygiene instructions
    Other Intervention Name(s)
    normal weight-PH patients
    Intervention Description
    Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush
    Primary Outcome Measure Information:
    Title
    Biochemical parameters (GSH and GSSG levels, GSH/GSSG ratio )
    Description
    The changes in levels of reduced and oxidized glutathione (GSH and GSSG) 1 month after periodontal treatment determined by ELISA. The changes in levels of GSH were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontitis and obesity.
    Time Frame
    Baseline and 1 month after treatment
    Secondary Outcome Measure Information:
    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 1 month after treatment
    Title
    Probing pocket depth and clinical attachment level
    Description
    The changes in clinical attachment level after periodontal treatment. The probing depth and the distance from the gingival margin to the cemento-enamel junction are used to measurement of clinical attachment level. Clinical attachment level was measured for determining severity of disease and clinic outcome.
    Time Frame
    Baseline and 1 month after treatment
    Title
    Gingival index
    Description
    he changes in gingival index after periodontal treatment. Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation.
    Time Frame
    Baseline and 1 month 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 1 month 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 1 month after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: never-smokers no history of systemic disease no patients had been under periodontal therapy and medicine for at least 6 months before the study no pregnancy or lactation no alcohol or antioxidant vitamin consumption. Exclusion Criteria: -

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Obesity on Glutathione Levels in Patients With Chronic Periodontitis Before and After Periodontal Therapy

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