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Evaluation of Periodontal Diseases and Obesity in Women

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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

Tracking Information
First Submitted Date  ICMJE February 9, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date February 22, 2018
Actual Study Start Date  ICMJE December 29, 2014
Actual Primary Completion Date June 11, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • Biochemical variables GCF [ Time Frame: 12 week ]
    TNF-A, IL-1B,concentrations levels (pg/µl)
  • Biochemical variables GCF [ Time Frame: 12 week ]
    Leptin, adiponectin, resistin concentrations levels (ng/µl)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • Biochemical variables_Saliva [ Time Frame: 12 week ]
    TNF-A, IL-1B,concentrations levels (pg/µl)
  • Biochemical variables_Saliva [ Time Frame: 12 week ]
    leptin, adiponectin, resistin concentrations levels (ng/µl)
  • Biochemical variables_Serum [ Time Frame: 12 week ]
    TNF-A, IL-1B,concentrations levels (pg/µl)
  • Biochemical variables_Serum [ Time Frame: 12 week ]
    leptin, adiponectin, resistin concentrations levels (ng/µl)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Periodontal Diseases and Obesity in Women
Official Title  ICMJE The Effects of Obesity and Periodontitis on Biochemical Parameters in Women Subjects
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)].
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Periodontal Diseases
  • Obesity
Intervention  ICMJE Other: Exercise
This group made exercise for 12 week/3 times a week.
Study Arms  ICMJE
  • Experimental: Obese women
    Obese women who participated exercise programme.
    Intervention: Other: Exercise
  • No Intervention: Normal weighted
    Normal weighted women with non-periodontitis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2018)
71
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 10, 2016
Actual Primary Completion Date June 11, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: adult women
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03442920
Other Study ID Numbers  ICMJE 114S144
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Esra Guzeldemir-Akcakanat, Kocaeli University
Study Sponsor  ICMJE Kocaeli University
Collaborators  ICMJE The Scientific and Technological Research Council of Turkey
Investigators  ICMJE Not Provided
PRS Account Kocaeli University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP