Polycystic Ovary Syndrome Clinical Trial
Official title:
Evaluation Of Lipid Peroxidation, Oxidative DNA Damage And Total Antioxidant Status In Patients With Periodontitis And Polycystic Ovary Syndrome: A Cross Sectional Study
NCT number | NCT02954120 |
Other study ID # | PCOSandCP |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | September 2015 |
Verified date | January 2020 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Background: The aim of this study was to investigate the levels of malondialdehyde (MDA),
total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and
saliva samples in female patients with chronic periodontitis (CP) and to compared healthy
individuals.
Materials and Methods: A total of 88 women were into four groups each which were consisted of
twenty-two subjects. Groups were designed as periodontally and systemically healthy women
(PCOS-CP-); periodontally healthy women with polycystic ovary syndrome (PCOS) (PCOS+CP-),
systemically healthy women with CP (PCOS-,CP+) and women with PCOS and CP (PCOS+CP+). Serum
and salivary samples were obtained, clinical periodontal parameters were recorded. MDA, TAS,
8-OHdG levels were measured as biochemically.
Status | Completed |
Enrollment | 88 |
Est. completion date | September 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Newly diagnosed non-obese PCOS patients - Never smokers - Had no history of systemic disease - BMI<25 kg/m2 - Participants had =20 teeth present. Exclusion Criteria: - Pregnancy - Lactation - Hemoglobin A1c (HbA1c) = 6.5% - 2-h oral glucose tolerance test (OGTT-2h) =200 - Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors - Any drug use within the past 6 months - Periodontal treatment within the past 6 months |
Country | Name | City | State |
---|---|---|---|
Turkey | Department of Periodontics, Faculty of Dentistry, Bezmialem Vakif University | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 8-OHdG levels (nanogram per mililiter(ng/mL)) | by ELISA test | appoximately 2 years | |
Primary | MDA levels (micromole per liter (µmol/L)) | by ELISA test | appoximately 2 years | |
Primary | TAS levels (millimolar per liter (mmol /L)) | by ELISA test | appoximately 2 years | |
Primary | Plaque Index (PI) | Silnes-Löe Periodondal Index | appoximately 2 years | |
Primary | Gingival Index (GI) | Löe-Silness Periodontal Index | appoximately 2 years | |
Primary | Bleeding on probing (BOP) | GIngival Bleeding Index | appoximately 2 years | |
Primary | Clinical attachment level (CAL) | by measuring the distance between the cementoenamel junction and the periodontal pocket base | Patients were seen one time | |
Primary | Probing pocket depth (PD)) | distance between free gingival margin and periodontal pocket base by usin periodontal probe | appoximately 2 years | |
Secondary | number of individuals with chronic periodontitis | individuals in the group | appoximately 2 years | |
Secondary | numberer of individuals with polycystic ovary syndrome | individuals in the group | appoximately 2 years |
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