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NCT Number: NCT03594968

Oxidative Stress in Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries Lesions

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

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Dental Caries Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Stomatognathic Diseases Tooth Demineralization Tooth Diseases Urogenital Diseases

Age range

18 year–24 year

Sex eligibility

Female

Study type

Observational

Primary location

Recep Tayyip Erdogan University

Rize, 53000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

polycystic ovary syndrome

Diagnostic Test

3 to 5th day of the women's normal cycle, we will perform a routine gynecological examination, a basic vaginal ultrasound, a basal hormone profile evaluation

Other names: [LH],, [total T],, [free T],, [DHEA-S],, 17-OH-progesterone, [FSH],

Primary outcomes

  1. FSH hormone ovarian morphology (PCOM)

    Time frame: 1 Day

    follicle-stimulating hormone [FSH] is tested by blood sample 6.3_24 mlu/ml

  2. luteinizing hormone

    Time frame: 1 day

    luteinizing hormone [LH] is tested by blood sample 1.68-15 U/L

  3. dehydroepiandrosterone-sulfate

    Time frame: 1 day

    dehydroepiandrosterone-sulfate [DHEA-S] is tested by blood sample 65 to 380 µg/dL or 1.75 to 10.26 µmol/L

  4. 17-OH-progesterone

    Time frame: 1 day

    17-OH-progesterone is tested by blood sample 20-100 ng/dL

Secondary outcomes

  1. dental examination

    Time frame: 1 Day

    All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II). The chosen sites were recorded as: 0 = sound;

    • = first visible sign of noncavitated lesion seen only when the tooth is dried;
    • = visible noncavitated lesion seen when wet and dry;
    • = microcavitation in enamel;
    • = noncavitated lesion extending into dentine seen as an undermining shadow;
    • = small cavitated lesion with visible dentine: less than 50% of surface;
    • = large cavitated lesions with visible dentine in more than 50% of the surface.

  2. periodontal examination

    Time frame: 1 Day

    A single calibrated examiner measured probing depth-PD, 0: healthy

    bleeding calculus 3:3.5-5.5 mm 4: over 5.5 mm

  3. Clinical attachment level

    Time frame: 1 Day

    A single calibrated examiner measured clinical attachment level- CAL, 0: 0-3 mm 1:4-5 mm 2:6-8 mm 3:over 8mm 4: 9-11 mm 5: over 12 mm

  4. Plaque Examination

    Time frame: 1 Day

    The plaque amount is scored by using Silness&Löe Plaque Index Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.

    0:no plaque

    • A film of plaque
    • soft deposit s within the gingival pocket
    • Abundance of soft matter within the gingival pocket.

    Calculation: Total scores of 6 (16, 12, 24, 36, 32, 44) teeth / No of surfaces examined

    Healthy = PI<0.4. Mild = PI 0.4-1.0. Moderate = PI 1.1-2. Severe = PI>2.

  5. Gingival Examination

    Time frame: 1 Day

    0= Normal gingiva;

    • Mild inflammation
    • Moderate inflammation
    • Severe inflammation Calculation: Total scores/ no of surfaces examined 0.1-1:Mild gingivitis, 1.1-2:moderate gingivitis; 2.1-3:severe gingivitis

  6. Bleeding Examination

    Time frame: 1 Day

    0: no bleeding

    1: bleeding

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 20, 2018
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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