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

Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries

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

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Dental Caries
• Intervention / Treatment: 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
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• Turkey
  • Rize, Turkey, 53000
    • Recep Tayyip Erdogan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 22 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients were aged from 18 to 24 years, 206 females

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
polycystic ovary syndrome (PCOS); Presence of ≥2 of the following: oligomenorrhea and/or anovulation; 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],

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FSH hormone ovarian morphology (PCOM)	follicle-stimulating hormone [FSH] is tested by blood sample 6.3_24 mlu/ml	1 Day
luteinizing hormone	luteinizing hormone [LH] is tested by blood sample 1.68-15 U/L	1 day
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
17-OH-progesterone	17-OH-progesterone is tested by blood sample 20-100 ng/dL	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Bleeding Examination	0: no bleeding 1: bleeding	1 Day

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• Polycystic Ovary Syndrome and Gingival Inflammation

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Stomatognathic Diseases; Mouth Diseases; Tooth Demineralization; Tooth Diseases; Polycystic Ovary Syndrome; Syndrome; Dental Caries; Periodontal Diseases; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 40986104-799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be available within 6 months of study finishing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No