NCT03594968

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

July 10, 2018

Last Update Submit

September 1, 2021

Conditions

Polycystic Ovary SyndromeDental Caries

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • dental examination

    1 Day

  • periodontal examination

    1 Day

  • Clinical attachment level

    1 Day

  • Plaque Examination

    1 Day

  • Gingival Examination

    1 Day

  • +1 more secondary outcomes

Study Arms (2)

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

healthy

healthy patients who had no polycystic ovary

Diagnostic Test: polycystic ovary syndrome

Interventions

polycystic ovary syndromeDIAGNOSTIC_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

Also known as: [LH],, [total T],, [free T],, [DHEA-S],, 17-OH-progesterone, [FSH],
healthypolycystic ovary syndrome (PCOS)

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients were aged from 18 to 24 years, 206 females

You may qualify if:

  • females with Polycystic Ovary Syndrome

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University

Rize, 53000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 22509751BACKGROUND

Related Links

MeSH Terms

Conditions

Polycystic Ovary SyndromeDental Caries

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Gül Yıldız Telatar

    Recep Tayyip Erdogan University Dentistry Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 10, 2018

First Posted

July 20, 2018

Study Start

April 15, 2018

Primary Completion

March 30, 2019

Study Completion

May 15, 2019

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Data will be available within 6 months of study finishing

Locations

TU(1)