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

Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03594968
Enrollment
206
Registered
2018-07-20
Start date
2018-04-15
Completion date
2019-05-15
Last updated
2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Polycystic Ovary Syndrome

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.

Interventions

DIAGNOSTIC_TESTpolycystic 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

Sponsors

Recep Tayyip Erdogan University Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 24 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
FSH hormone ovarian morphology (PCOM)1 Dayfollicle-stimulating hormone \[FSH\] is tested by blood sample 6.3\_24 mlu/ml
luteinizing hormone1 dayluteinizing hormone \[LH\] is tested by blood sample 1.68-15 U/L
dehydroepiandrosterone-sulfate1 daydehydroepiandrosterone-sulfate \[DHEA-S\] is tested by blood sample 65 to 380 µg/dL or 1.75 to 10.26 µmol/L
17-OH-progesterone1 day17-OH-progesterone is tested by blood sample 20-100 ng/dL

Secondary

MeasureTime frameDescription
Gingival Examination1 Day0= 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
dental examination1 DayAll 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.
Bleeding Examination1 Day0: no bleeding 1: bleeding
periodontal examination1 DayA single calibrated examiner measured probing depth-PD, 0: healthy bleeding calculus 3:3.5-5.5 mm 4: over 5.5 mm
Clinical attachment level1 DayA 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
Plaque Examination1 DayThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026