Back to resultsEvaluation of Periodontal Diseases and Obesity in Women
Primary Purpose
Periodontal Diseases, Obesity
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontal Diseases focused on measuring obesity, periodontal diseases, gingival crevicular fluid, saliva, serum
Eligibility 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
Sites / Locations
- Kocaeli University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Obese women
Normal weighted
Arm Description
Obese women who participated exercise programme.
Normal weighted women with non-periodontitis
Outcomes
Primary Outcome Measures
Biochemical variables GCF
TNF-A, IL-1B,concentrations levels (pg/µl)
Biochemical variables GCF
Leptin, adiponectin, resistin concentrations levels (ng/µl)
Secondary Outcome Measures
Biochemical variables_Saliva
TNF-A, IL-1B,concentrations levels (pg/µl)
Biochemical variables_Saliva
leptin, adiponectin, resistin concentrations levels (ng/µl)
Biochemical variables_Serum
TNF-A, IL-1B,concentrations levels (pg/µl)
Biochemical variables_Serum
leptin, adiponectin, resistin concentrations levels (ng/µl)
Full Information
NCT ID
NCT03442920
First Posted
February 9, 2018
Last Updated
February 21, 2018
Sponsor
Kirsehir Ahi Evran University
Collaborators
The Scientific and Technological Research Council of Turkey
1. Study Identification
Unique Protocol Identification Number
NCT03442920
Brief Title
Evaluation of Periodontal Diseases and Obesity in Women
Official Title
The Effects of Obesity and Periodontitis on Biochemical Parameters in Women Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 29, 2014 (Actual)
Primary Completion Date
June 11, 2015 (Actual)
Study Completion Date
January 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
Collaborators
The Scientific and Technological Research Council of Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Obesity
Keywords
obesity, periodontal diseases, gingival crevicular fluid, saliva, serum
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese women
Arm Type
Experimental
Arm Description
Obese women who participated exercise programme.
Arm Title
Normal weighted
Arm Type
No Intervention
Arm Description
Normal weighted women with non-periodontitis
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
This group made exercise for 12 week/3 times a week.
Primary Outcome Measure Information:
Title
Biochemical variables GCF
Description
TNF-A, IL-1B,concentrations levels (pg/µl)
Time Frame
12 week
Title
Biochemical variables GCF
Description
Leptin, adiponectin, resistin concentrations levels (ng/µl)
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Biochemical variables_Saliva
Description
TNF-A, IL-1B,concentrations levels (pg/µl)
Time Frame
12 week
Title
Biochemical variables_Saliva
Description
leptin, adiponectin, resistin concentrations levels (ng/µl)
Time Frame
12 week
Title
Biochemical variables_Serum
Description
TNF-A, IL-1B,concentrations levels (pg/µl)
Time Frame
12 week
Title
Biochemical variables_Serum
Description
leptin, adiponectin, resistin concentrations levels (ng/µl)
Time Frame
12 week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
adult women
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
ZIP/Postal Code
41190
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Periodontal Diseases and Obesity in Women
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