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

About this trial
This is an interventional diagnostic trial for Obesity
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:
-
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
NCT ID
NCT02498561
First Posted
July 9, 2015
Last Updated
July 14, 2015
Sponsor
Figen ÖNGÖZ DEDE
Collaborators
Bulent Ecevit University
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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