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

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ClinicalTrials.gov Identifier: NCT03594968
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital

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

Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Dental Caries Oxidative Stress Diagnostic Test: polycystic ovary syndrome

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.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
polycystic ovary syndrome (PCOS)

Presence of ≥2 of the following:

  1. oligomenorrhea and/or anovulation
  2. Hyperandrogenism (clinical and/or biochemical) One of the signs for clinical hyperandrogenism is hirsutism, which represents hair growth in a male pattern on a female with four different degrees of severity in 11 different body parts: 1) upper lip; 2) chin; 3) chest; 4) upper back; 5) lower back; 6) upper abdomen; 7) lower abdomen; 8) arm; 9) forearm; 10) thigh; and 11) lower leg. The Ferriman-Gallwey scoring system is used to score the degree of excess male-pattern body hair to indicate hirsutism.
Diagnostic Test: polycystic ovary syndrome
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],

healthy
healthy patients who had no polycystic ovary
Diagnostic Test: polycystic ovary syndrome
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 Outcome Measures :
  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 Outcome Measures :
  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;

    1. = first visible sign of noncavitated lesion seen only when the tooth is dried;
    2. = visible noncavitated lesion seen when wet and dry;
    3. = microcavitation in enamel;
    4. = noncavitated lesion extending into dentine seen as an undermining shadow;
    5. = small cavitated lesion with visible dentine: less than 50% of surface;
    6. = 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

    1. A film of plaque
    2. soft deposit s within the gingival pocket
    3. 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;

    1. Mild inflammation
    2. Moderate inflammation
    3. 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




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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients were aged from 18 to 24 years, 100 females
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594968


Contacts
Contact: Gül Yıldız Telatar, Dr. 05365404555 gulyildiz@gmail.com
Contact: Beril Gürlek, Dr. 05535979403 berilsem@yahoo.com

Locations
Turkey
Recep Tayyip Erdogan University Recruiting
Rize, Turkey, 53000
Contact: Gül Yıldız Telatar    05365404555    gulyildiz@gmail.com   
Contact: Beril Gürlek    05535979403    berilsem@yahoo.com   
Sponsors and Collaborators
Recep Tayyip Erdogan University Training and Research Hospital
Investigators
Principal Investigator: Gül Yıldız Telatar Recep Tayyip Erdogan University Dentistry Faculty

Additional Information:
Publications:
Responsible Party: Gul Yildiz Telatar, Assistant Professor, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03594968     History of Changes
Other Study ID Numbers: 40986104-799
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available within 6 months of study finishing

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Dental Caries
Periodontal Diseases
Gingival Diseases
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Mouth Diseases
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs