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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594968
• Other study ID #: 40986104-799
• Status: Completed
• Start date: April 15, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: September 2021
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: May 15, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Periodontal Diseases
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Recep Tayyip Erdogan University	Rize

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Özçaka Ö, Ceyhan BÖ, Akcali A, Biçakci 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FSH hormone ovarian morphology (PCOM)	follicle-stimulating hormone [FSH] is tested by blood sample 6.3_24 mlu/ml	1 Day
Primary	luteinizing hormone	luteinizing hormone [LH] is tested by blood sample 1.68-15 U/L	1 day
Primary	dehydroepiandrosterone-sulfate	dehydroepiandrosterone-sulfate [DHEA-S] is tested by blood sample 65 to 380 µg/dL or 1.75 to 10.26 µmol/L	1 day
Primary	17-OH-progesterone	17-OH-progesterone is tested by blood sample 20-100 ng/dL	1 day
Secondary	dental examination	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.	1 Day
Secondary	periodontal examination	A single calibrated examiner measured probing depth-PD, 0: healthy; bleeding calculus 3:3.5-5.5 mm 4: over 5.5 mm	1 Day
Secondary	Clinical attachment level	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	1 Day
Secondary	Plaque Examination	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.	1 Day
Secondary	Gingival Examination	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	1 Day
Secondary	Bleeding Examination	0: no bleeding; 1: bleeding	1 Day

External Links

•   Polycystic Ovary Syndrome and Gingival Inflammation