Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Periodontal Diseases and Obesity in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03442920
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
The Scientific and Technological Research Council of Turkey
Information provided by (Responsible Party):
Esra Guzeldemir-Akcakanat, Kocaeli University

Brief Summary:
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)].

Condition or disease Intervention/treatment Phase
Periodontal Diseases Obesity Other: Exercise Not Applicable

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)].

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effects of Obesity and Periodontitis on Biochemical Parameters in Women Subjects
Actual Study Start Date : December 29, 2014
Actual Primary Completion Date : June 11, 2015
Actual Study Completion Date : January 10, 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Biochemical variables GCF [ Time Frame: 12 week ]
    TNF-A, IL-1B,concentrations levels (pg/µl)

  2. Biochemical variables GCF [ Time Frame: 12 week ]
    Leptin, adiponectin, resistin concentrations levels (ng/µl)


Secondary Outcome Measures :
  1. Biochemical variables_Saliva [ Time Frame: 12 week ]
    TNF-A, IL-1B,concentrations levels (pg/µl)

  2. Biochemical variables_Saliva [ Time Frame: 12 week ]
    leptin, adiponectin, resistin concentrations levels (ng/µl)

  3. Biochemical variables_Serum [ Time Frame: 12 week ]
    TNF-A, IL-1B,concentrations levels (pg/µl)

  4. Biochemical variables_Serum [ Time Frame: 12 week ]
    leptin, adiponectin, resistin concentrations levels (ng/µl)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   adult women
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442920


Locations
Layout table for location information
Turkey
Kocaeli University
Kocaeli, Turkey, 41190
Sponsors and Collaborators
Kocaeli University
The Scientific and Technological Research Council of Turkey

Layout table for additonal information
Responsible Party: Esra Guzeldemir-Akcakanat, Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT03442920     History of Changes
Other Study ID Numbers: 114S144
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Esra Guzeldemir-Akcakanat, Kocaeli University:
obesity
periodontal diseases
gingival crevicular fluid
saliva
serum
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontal Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases