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Polycystic Ovary SyndromeNCT03594968

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

An observational study of Polycystic Ovary Syndrome and Dental Caries, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 24 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome, Dental Caries
What is being tested?
polycystic ovary syndrome
How many people
206 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Apr 2018to 15 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Patients were aged from 18 to 24 years, 206 females

Who may be able to join

  • females with Polycystic Ovary Syndrome

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Recep Tayyip Erdogan University

    Rize, 53000

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the 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.

Being tested
polycystic ovary syndrome
Medical subject headings
Polycystic Ovary Syndrome, Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • polycystic ovary syndromeDiagnostic test

    Also called [LH],, [total T],, [free T],, [DHEA-S],

    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

Study groups in NCT03594968
Study groupRoleWhat they receive
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.
Receives: Diagnostic Test: polycystic ovary syndrome
healthyhealthy patients who had no polycystic ovary
Receives: Diagnostic Test: polycystic ovary syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FSH hormone ovarian morphology (PCOM)

    follicle-stimulating hormone [FSH] is tested by blood sample 6.3_24 mlu/ml

    Measured: 1 Day

  2. luteinizing hormone

    luteinizing hormone [LH] is tested by blood sample 1.68-15 U/L

    Measured: 1 day

  3. dehydroepiandrosterone-sulfate

    dehydroepiandrosterone-sulfate [DHEA-S] is tested by blood sample 65 to 380 µg/dL or 1.75 to 10.26 µmol/L

    Measured: 1 day

  4. 17-OH-progesterone

    17-OH-progesterone is tested by blood sample 20-100 ng/dL

    Measured: 1 day

Secondary outcomes (6)

  1. dental examination

    All 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.

    Measured: 1 Day

  2. 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

    Measured: 1 Day

  3. 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

    Measured: 1 Day

  4. 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

    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.

    Measured: 1 Day

  5. Gingival Examination

    0= 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

    Measured: 1 Day

  6. Bleeding Examination

    0: no bleeding

    1: bleeding

    Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2018
  2. Study start15 Apr 2018
  3. Primary completion30 Mar 2019
  4. Study completion15 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03594968
Sponsor's protocol ID
40986104-799
Status last verified
Sep 2021
First submitted
10 Jul 2018
Last updated
9 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be available within 6 months of study finishing

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.

    PubMed 22509751

Questions about this trial

What is this clinical trial studying?

An observational study of Polycystic Ovary Syndrome and Dental Caries, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FSH hormone ovarian morphology (PCOM) (time frame: 1 Day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03594968, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.

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