- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02954120
Chronic Periodontitis and Polycystic Ovary Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Fatih
-
İstanbul, Fatih, Turkey, 34093
- Department of Periodontics, Faculty of Dentistry, Bezmialem Vakif University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed non-obese PCOS patients
- Never smokers
- Had no history of systemic disease
- BMI<25 kg/m2
- Participants had ≥20 teeth present.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
(PCOS-CP-)
systemically and periodontally healthy participants
|
|
|
(PCOS-CP+)
systemically healthy participants with CP
|
|
|
(PCOS+CP-)
PCOS participants with periodontally healthy
|
|
|
(PCOS+CP+)
PCOS participants with CP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
8-OHdG levels (nanogram per mililiter(ng/mL))
Time Frame: appoximately 2 years
|
by ELISA test
|
appoximately 2 years
|
|
MDA levels (micromole per liter (µmol/L))
Time Frame: appoximately 2 years
|
by ELISA test
|
appoximately 2 years
|
|
TAS levels (millimolar per liter (mmol /L))
Time Frame: appoximately 2 years
|
by ELISA test
|
appoximately 2 years
|
|
Plaque Index (PI)
Time Frame: appoximately 2 years
|
Silnes-Löe Periodondal İndex
|
appoximately 2 years
|
|
Gingival Index (GI)
Time Frame: appoximately 2 years
|
Löe-Silness Periodontal Index
|
appoximately 2 years
|
|
Bleeding on probing (BOP)
Time Frame: appoximately 2 years
|
Gİngival Bleeding Index
|
appoximately 2 years
|
|
Clinical attachment level (CAL)
Time Frame: Patients were seen one time
|
by measuring the distance between the cementoenamel junction and the periodontal pocket base
|
Patients were seen one time
|
|
Probing pocket depth (PD))
Time Frame: appoximately 2 years
|
distance between free gingival margin and periodontal pocket base by usin periodontal probe
|
appoximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of individuals with chronic periodontitis
Time Frame: appoximately 2 years
|
individuals in the group
|
appoximately 2 years
|
|
numberer of individuals with polycystic ovary syndrome
Time Frame: appoximately 2 years
|
individuals in the group
|
appoximately 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nesrin Saruhan, PhD, Eskisehir Osmangazi Universitesi
- Study Director: Cenk Fatih Çanakcı, Prof, Atatürk Üniversitesi
- Principal Investigator: Saime Ozbek Sebin, Dr, Atatürk Üniversitesi
- Principal Investigator: Humeyra Canakcı, Dr, Buhara Hastanesi
- Principal Investigator: Metin İngeç, Prof, Atatürk Üniversitesi
- Principal Investigator: Ufuk Sezer, Phd, Özel Klinik
- Principal Investigator: Ebru Saglam, PhD, Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCOSandCP
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