Evaluation of Periodontal Diseases and Obesity in Women

Sponsor

Kocaeli University (Other)

Overall Status

Completed

CT.gov ID

NCT03442920

Collaborator

The Scientific and Technological Research Council of Turkey (Other)

Enrollment

Location

Arms

12.4

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

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)].

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases Obesity	Other: Exercise	N/A

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 Design

Study Type:

Interventional

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 :

Dec 29, 2014

Actual Primary Completion Date :

Jun 11, 2015

Actual Study Completion Date :

Jan 10, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Biochemical variables GCF [12 week]
TNF-A, IL-1B,concentrations levels (pg/µl)
Biochemical variables GCF [12 week]
Leptin, adiponectin, resistin concentrations levels (ng/µl)

Secondary Outcome Measures

Biochemical variables_Saliva [12 week]
TNF-A, IL-1B,concentrations levels (pg/µl)
Biochemical variables_Saliva [12 week]
leptin, adiponectin, resistin concentrations levels (ng/µl)
Biochemical variables_Serum [12 week]
TNF-A, IL-1B,concentrations levels (pg/µl)
Biochemical variables_Serum [12 week]
leptin, adiponectin, resistin concentrations levels (ng/µl)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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