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

NCT ID: NCT02498561

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-01-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

obese-chronic periodontitis patients

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

Group Type: ACTIVE_COMPARATOR

nonsurgical periodontal therapy

Intervention Type: PROCEDURE

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.

obese-periodontally healthy controls

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

Group Type: PLACEBO_COMPARATOR

oral hygiene instructions

Intervention Type: PROCEDURE

Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush

normal weight-CP patients

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

Group Type: ACTIVE_COMPARATOR

nonsurgical periodontal therapy

Intervention Type: PROCEDURE

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.

normal weight-PH controls

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

Group Type: PLACEBO_COMPARATOR

oral hygiene instructions

Intervention Type: PROCEDURE

Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Other Intervention Names

obese-chronic periodontitis patients; obese-periodontally healthy controls; normal weight-CP patients; normal weight-PH patients

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

-

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bulent Ecevit University

OTHER

Sponsor Role: collaborator

Figen ÖNGÖZ DEDE

OTHER

Sponsor Role: lead

Responsible Party

Figen ÖNGÖZ DEDE

Faculty of Dentistry

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2013-62550515-02

Identifier Type: -

Identifier Source: org_study_id