- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498561
The Effects of Obesity on Glutathione Levels in Patients With Chronic Periodontitis Before and After Periodontal Therapy
Phase 1 Study of Periodontal Disease and Obese Individuals That Investigate of Local and Systemic Antioxidant Levels of Before and After Periodontal Treatment
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: obese-chronic periodontitis patients
GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy
|
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.
Other Names:
|
Placebo Comparator: obese-periodontally healthy controls
GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions
|
Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush
Other Names:
|
Active Comparator: normal weight-CP patients
GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy
|
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.
Other Names:
|
Placebo Comparator: normal weight-PH controls
GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions
|
Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical parameters (GSH and GSSG levels, GSH/GSSG ratio )
Time Frame: Baseline and 1 month after treatment
|
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.
|
Baseline and 1 month after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing pocket depth
Time Frame: Baseline and 1 month 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 1 month after treatment
|
Probing pocket depth and clinical attachment level
Time Frame: Baseline and 1 month after treatment
|
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.
|
Baseline and 1 month after treatment
|
Plaque index
Time Frame: Baseline and 1 month after treatment
|
The changes in plaque index after periodontal treatment.
Plaque index was recorded for determining and classifying oral hygiene status.
|
Baseline and 1 month after treatment
|
Bleeding on probing
Time Frame: Baseline and 1 month 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 1 month after treatment
|
Gingival index
Time Frame: Baseline and 1 month after treatment
|
he changes in gingival index after periodontal treatment.
Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation.
|
Baseline and 1 month after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-62550515-02
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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