Polycystic Ovary SyndromeNCT02954120
Chronic Periodontitis and Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome and Chronic Periodontitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Background: The aim of this study was to investigate the levels of malondialdehyde (MDA), total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and saliva samples in female patients with chronic periodontitis (CP) and to compared healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Chronic Periodontitis
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2013to Sep 2015
- How long will I take part?
- 1 Day
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All participants were recruited among women at the Department of Obstetrics and Gynecology, School of Medicine, Ataturk University
Who may be able to join
- Newly diagnosed non-obese PCOS patients
- Never smokers
- Had no history of systemic disease
- BMI<25 kg/m2
- Participants had ≥20 teeth present.
Who cannot join
- Pregnancy
- Lactation
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- 2-h oral glucose tolerance test (OGTT-2h) ≥200
- Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors
- Any drug use within the past 6 months
- Periodontal treatment within the past 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Periodontics, Faculty of Dentistry, Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: Evaluation Of Lipid Peroxidation, Oxidative DNA Damage And Total Antioxidant Status In Patients With Periodontitis And Polycystic Ovary Syndrome: A Cross Sectional Study
Background: The aim of this study was to investigate the levels of malondialdehyde (MDA), total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and saliva samples in female patients with chronic periodontitis (CP) and to compared healthy individuals.
Materials and Methods: A total of 88 women were into four groups each which were consisted of twenty-two subjects. Groups were designed as periodontally and systemically healthy women (PCOS-CP-); periodontally healthy women with polycystic ovary syndrome (PCOS) (PCOS+CP-), systemically healthy women with CP (PCOS-,CP+) and women with PCOS and CP (PCOS+CP+). Serum and salivary samples were obtained, clinical periodontal parameters were recorded. MDA, TAS, 8-OHdG levels were measured as biochemically.
Read the detailed description
RESULTS:
Salivary 8-OHdG levels in the PCOSCP and CP groups were statistically higher than those in both the PCOSPH and the PH groups (P < 0.05). There was no statistical difference between the PCOSCP, CP, and PCOSPH groups with regard to salivary MDA and TAS levels (P > 0.05). Highest serum 8-OHdG and MDA levels and lowest serum TAS levels were seen in the PCOSCP group (P < 0.05). Serum 8-OHdG and MDA levels in the PCOSPH group were higher than those in both systemically healthy groups (PH and CP) (P < 0.05). Salivary TAS levels were highest (P < 0.05) in the PH group. There was no statistical difference between the CP and PCOSPH groups, but serum TAS levels were lower than those in the PH group (P < 0.05).
CONCLUSIONS:
CP, which led to an increase in serum and salivary 8-OHdG and MDA levels and a decrease in serum TAS levels in patients with PCOS, contributed to increased OS. This effect was more prominent in serum levels than in salivary levels.
- Conditions
- Polycystic Ovary Syndrome, Chronic Periodontitis
- Being tested
- no intervention provided
- Keywords
- 8- hydroxy -2´- deoxyguanosine, Malondialdehyde, Total antioxidant status, Oxidative stres
- Medical subject headings
- Polycystic Ovary Syndrome, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention providedOther
| Study group | Role | What they receive |
|---|---|---|
| (PCOS-CP-) | systemically and periodontally healthy participants Receives: Other: no intervention provided | |
| (PCOS-CP+) | systemically healthy participants with CP Receives: Other: no intervention provided | |
| (PCOS+CP-) | PCOS participants with periodontally healthy Receives: Other: no intervention provided | |
| (PCOS+CP+) | PCOS participants with CP Receives: Other: no intervention provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-OHdG levels (nanogram per mililiter(ng/mL))
by ELISA test
Measured: appoximately 2 years
MDA levels (micromole per liter (µmol/L))
by ELISA test
Measured: appoximately 2 years
TAS levels (millimolar per liter (mmol /L))
by ELISA test
Measured: appoximately 2 years
Plaque Index (PI)
Silnes-Löe Periodondal İndex
Measured: appoximately 2 years
Gingival Index (GI)
Löe-Silness Periodontal Index
Measured: appoximately 2 years
Bleeding on probing (BOP)
Gİngival Bleeding Index
Measured: appoximately 2 years
Clinical attachment level (CAL)
by measuring the distance between the cementoenamel junction and the periodontal pocket base
Measured: Patients were seen one time
Probing pocket depth (PD))
distance between free gingival margin and periodontal pocket base by usin periodontal probe
Measured: appoximately 2 years
Secondary outcomes (2)
number of individuals with chronic periodontitis
individuals in the group
Measured: appoximately 2 years
numberer of individuals with polycystic ovary syndrome
individuals in the group
Measured: appoximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startMay 2013
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 88 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nesrin Saruhan, PhD, Principal investigator, Eskisehir Osmangazi ÜniversitesiCenk Fatih Çanakcı, Prof, Study director, Ataturk UniversitySaime Ozbek Sebin, Dr, Principal investigator, Ataturk UniversityHumeyra Canakcı, Dr, Principal investigator, Buhara HastanesiMetin İngeç, Prof, Principal investigator, Ataturk UniversityUfuk Sezer, Phd, Principal investigator, Özel KlinikEbru Saglam, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954120
- Sponsor's protocol ID
- PCOSandCP
- Status last verified
- Jan 2020
- First submitted
- 28 Oct 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Lipid Peroxidation, Oxidative DNA Damage And Total Antioxidant Status In Patients With Periodontitis And Polycystic Ovary Syndrome: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT02954120
- Acronym / sponsor ID
- PCOSandCP
- Conditions
- Polycystic Ovary Syndrome, Chronic Periodontitis
- Keywords
- 8- hydroxy -2´- deoxyguanosine, Malondialdehyde, Total antioxidant status, Oxidative stres
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The aim of this study was to investigate the levels of malondialdehyde (MDA), total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and saliva samples in female patients with chronic periodontitis (CP) and to compared healthy individuals.
Materials and Methods: A total of 88 women were into four groups each which were consisted of twenty-two subjects. Groups were designed as periodontally and systemically healthy women (PCOS-CP-); periodontally healthy women with polycystic ovary syndrome (PCOS) (PCOS+CP-), systemically healthy women with CP (PCOS-,CP+) and women with PCOS and CP (PCOS+CP+). Serum and salivary samples were obtained, clinical periodontal parameters were recorded. MDA, TAS, 8-OHdG levels were measured as biochemically.
Detailed description
RESULTS:
Salivary 8-OHdG levels in the PCOSCP and CP groups were statistically higher than those in both the PCOSPH and the PH groups (P < 0.05). There was no statistical difference between the PCOSCP, CP, and PCOSPH groups with regard to salivary MDA and TAS levels (P > 0.05). Highest serum 8-OHdG and MDA levels and lowest serum TAS levels were seen in the PCOSCP group (P < 0.05). Serum 8-OHdG and MDA levels in the PCOSPH group were higher than those in both systemically healthy groups (PH and CP) (P < 0.05). Salivary TAS levels were highest (P < 0.05) in the PH group. There was no statistical difference between the CP and PCOSPH groups, but serum TAS levels were lower than those in the PH group (P < 0.05).
CONCLUSIONS:
CP, which led to an increase in serum and salivary 8-OHdG and MDA levels and a decrease in serum TAS levels in patients with PCOS, contributed to increased OS. This effect was more prominent in serum levels than in salivary levels.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| (PCOS-CP-) | – | Other: no intervention providedsystemically and periodontally healthy participants |
| (PCOS-CP+) | – | Other: no intervention providedsystemically healthy participants with CP |
| (PCOS+CP-) | – | Other: no intervention providedPCOS participants with periodontally healthy |
| (PCOS+CP+) | – | Other: no intervention providedPCOS participants with CP |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All participants were recruited among women at the Department of Obstetrics and Gynecology, School of Medicine, Ataturk University
Key inclusion criteria (5 listed)
- Newly diagnosed non-obese PCOS patients
- Never smokers
- Had no history of systemic disease
- BMI<25 kg/m2
- Participants had ≥20 teeth present.
Key exclusion criteria (7 listed)
- Pregnancy
- Lactation
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- 2-h oral glucose tolerance test (OGTT-2h) ≥200
- Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention provided | Other | (PCOS+CP+), (PCOS+CP-), (PCOS-CP+), (PCOS-CP-) |
Primary outcome
8-OHdG levels (nanogram per mililiter(ng/mL))
Time frame: appoximately 2 years
by ELISA test
MDA levels (micromole per liter (µmol/L))
Time frame: appoximately 2 years
by ELISA test
TAS levels (millimolar per liter (mmol /L))
Time frame: appoximately 2 years
by ELISA test
Plaque Index (PI)
Time frame: appoximately 2 years
Silnes-Löe Periodondal İndex
Gingival Index (GI)
Time frame: appoximately 2 years
Löe-Silness Periodontal Index
Bleeding on probing (BOP)
Time frame: appoximately 2 years
Gİngival Bleeding Index
Clinical attachment level (CAL)
Time frame: Patients were seen one time
by measuring the distance between the cementoenamel junction and the periodontal pocket base
Probing pocket depth (PD))
Time frame: appoximately 2 years
distance between free gingival margin and periodontal pocket base by usin periodontal probe
2 secondary outcomes
number of individuals with chronic periodontitis
Time frame: appoximately 2 years
numberer of individuals with polycystic ovary syndrome
Time frame: appoximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nesrin Saruhan, PhD principal investigator
Eskisehir Osmangazi Üniversitesi
Cenk Fatih Çanakcı, Prof study director
Ataturk University
Saime Ozbek Sebin, Dr principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Chronic Periodontitis, run by Bezmialem Vakif University 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 5 inclusion and 7 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 18 Jan 2020. 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?
8-OHdG levels (nanogram per mililiter(ng/mL)) (time frame: appoximately 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2020.