Evaluation of Periodontal Diseases and Obesity in Women

February 21, 2018 updated by: Esra Guzeldemir-Akcakanat, Kocaeli University

The Effects of Obesity and Periodontitis on Biochemical Parameters in Women Subjects

The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters [serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is thought that adipokines may play a role on periodontal disease in obese subjects, periodontal disease may also aggravate the existing systemic disease by changing the inflammatory parameters in the body. The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters [serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)].

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41190
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Being women,
  • Older than 18 yrs old,
  • Not being pregnant,
  • Not being disabled,
  • For study group; being obese, not for healthy group being systemically health and in normal weight
  • Not treated periodontological in the last 6 months

Exclusion Criteria:

  • Younger than 18 yrs old,
  • Smokers who smokes more than 10 cigarettes in a day,
  • Uncontrolled systemic diseases,
  • Having periodontal treatment
  • who needs antibiotic prophylaxis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese women
Obese women who participated exercise programme.
Other: Exercise
This group made exercise for 12 week/3 times a week.
No Intervention: Normal weighted
Normal weighted women with non-periodontitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical variables GCF
Time Frame: 12 week
TNF-A, IL-1B,concentrations levels (pg/µl)
12 week
Biochemical variables GCF
Time Frame: 12 week
Leptin, adiponectin, resistin concentrations levels (ng/µl)
12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical variables_Saliva
Time Frame: 12 week
TNF-A, IL-1B,concentrations levels (pg/µl)
12 week
Biochemical variables_Saliva
Time Frame: 12 week
leptin, adiponectin, resistin concentrations levels (ng/µl)
12 week
Biochemical variables_Serum
Time Frame: 12 week
TNF-A, IL-1B,concentrations levels (pg/µl)
12 week
Biochemical variables_Serum
Time Frame: 12 week
leptin, adiponectin, resistin concentrations levels (ng/µl)
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Collaborators

The Scientific and Technological Research Council of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2014

Primary Completion (Actual)

June 11, 2015

Study Completion (Actual)

January 10, 2016

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114S144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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