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

NCT ID: NCT03594968

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-15

Study Completion Date

2019-05-15

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome Dental Caries

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

polycystic ovary syndrome

Intervention Type 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

healthy

healthy patients who had no polycystic ovary

polycystic ovary syndrome

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gul Yildiz Telatar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gül Yıldız Telatar

Role: PRINCIPAL_INVESTIGATOR

Recep Tayyip Erdogan University Dentistry Faculty

Locations

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Recep Tayyip Erdogan University

Rize, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22509751 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/22509751

Polycystic Ovary Syndrome and Gingival Inflammation

Other Identifiers

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40986104-799

Identifier Type: -

Identifier Source: org_study_id

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