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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02954120
Date of registration: 28/10/2016
Prospective Registration: No
Primary sponsor: Bezmialem Vakif University
Public title: Chronic Periodontitis and Polycystic Ovary Syndrome
Scientific title: Evaluation Of Lipid Peroxidation, Oxidative DNA Damage And Total Antioxidant Status In Patients With Periodontitis And Polycystic Ovary Syndrome: A Cross Sectional Study
Date of first enrolment: May 2013
Target sample size: 88
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02954120
Study type:  Observational [Patient Registry]
Study design:   
Phase: 
Countries of recruitment
Turkey
Contacts
Name:     Ufuk Sezer, Phd
Address: 
Telephone:
Email:
Affiliation:  Özel Klinik
Name:     Nesrin Saruhan, PhD
Address: 
Telephone:
Email:
Affiliation:  Eskisehir Osmangazi Üniversitesi
Name:     Metin Ingeç, Prof
Address: 
Telephone:
Email:
Affiliation:  Atatürk Üniversitesi
Name:     Humeyra Canakci, Dr
Address: 
Telephone:
Email:
Affiliation:  Buhara Hastanesi
Name:     Cenk Fatih Çanakci, Prof
Address: 
Telephone:
Email:
Affiliation:  Atatürk Üniversitesi
Name:     Saime Ozbek Sebin, Dr
Address: 
Telephone:
Email:
Affiliation:  Atatürk Üniversitesi
Name:     Ebru Saglam, PhD
Address: 
Telephone:
Email:
Affiliation:  Saglik Bilimleri Universitesi
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Polycystic Ovary Syndrome
Chronic Periodontitis
Intervention(s)
Other: no intervention provided
Primary Outcome(s)
Clinical attachment level (CAL) [Time Frame: Patients were seen one time]
Gingival Index (GI) [Time Frame: appoximately 2 years]
MDA levels (micromole per liter (µmol/L)) [Time Frame: appoximately 2 years]
Plaque Index (PI) [Time Frame: appoximately 2 years]
8-OHdG levels (nanogram per mililiter(ng/mL)) [Time Frame: appoximately 2 years]
Bleeding on probing (BOP) [Time Frame: appoximately 2 years]
TAS levels (millimolar per liter (mmol /L)) [Time Frame: appoximately 2 years]
Probing pocket depth (PD)) [Time Frame: appoximately 2 years]
Secondary Outcome(s)
numberer of individuals with polycystic ovary syndrome [Time Frame: appoximately 2 years]
number of individuals with chronic periodontitis [Time Frame: appoximately 2 years]
Secondary ID(s)
PCOSandCP
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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