Clinical trial NCT03594968: Oxidative Stress in Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries Lesions
Official title: Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Dental Caries
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were aged from 18 to 24 years, 206 females

Brief summary: This study evaluates the oxidative stress parameters in females with polycystic ovary syndrome (PCOS) and clinically healthy. Because of the fact that both oral disease included periodontitis and dental caries, and metabolic syndrome are associated with systemic inflammation, these two disorders may be linked through a common pathophysiologic pathway

Detailed description: Power analysis was performed with the G-Power software package to determine sample size. To cover possible data loss, 10% of a group were added to each group. Medical and dental examination will be performed both of control and experimental groups. Age and body mass index (BMI) will be recorded.

In dental examination decayed, missing, or filled teeth (DMFT) index will be used according to World Health Organization (WHO 1997) criteria. All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II). To analyze the correlation between oral health status and polycystic ovary syndrome linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.

Eligibility criteria: Inclusion Criteria:

* females with Polycystic Ovary Syndrome

Exclusion Criteria:

* history of ovarian surgery, patients with thyroid or prolactin hormone level abnormalities, non-classic 21-hydroxylase deficiency and hormonal therapy, steroid drug use past 6 months, obese patients (body mass index, BMI \> 35), acute or chronic upper respiratory tract diseases, dental fluorosis, patients using fluoride supplements or orthodontic appliances will not be included in the study.

Primary outcomes:
measure: FSH hormone ovarian morphology (PCOM)
timeFrame: 1 Day
measure: luteinizing hormone
timeFrame: 1 day
measure: dehydroepiandrosterone-sulfate
timeFrame: 1 day
measure: 17-OH-progesterone
timeFrame: 1 day
Secondary outcomes:
measure: dental examination
timeFrame: 1 Day
measure: periodontal examination
timeFrame: 1 Day
measure: Clinical attachment level
timeFrame: 1 Day
measure: Plaque Examination
timeFrame: 1 Day
measure: Gingival Examination
timeFrame: 1 Day
measure: Bleeding Examination
timeFrame: 1 Day
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University
Study officials:
affiliation: Recep Tayyip Erdogan University Dentistry Faculty
name: Gül Yıldız Telatar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozcaka O, Ceyhan BO, Akcali A, Bicakci N, Lappin DF, Buduneli N. Is there an interaction between polycystic ovary syndrome and gingival inflammation? J Periodontol. 2012 Dec;83(12):1529-37. doi: 10.1902/jop.2012.110588. Epub 2012 Apr 17.