Clinical trial NCT02954120: Chronic Periodontitis and Polycystic Ovary Syndrome
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Chronic Periodontitis
Keywords: 8- hydroxy -2´- deoxyguanosine
Malondialdehyde
Total antioxidant status
Oxidative stres
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants were recruited among women at the Department of Obstetrics and Gynecology, School of Medicine, Ataturk University

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 8-OHdG levels (nanogram per mililiter(ng/mL))
timeFrame: appoximately 2 years
measure: MDA levels (micromole per liter (µmol/L))
timeFrame: appoximately 2 years
measure: TAS levels (millimolar per liter (mmol /L))
timeFrame: appoximately 2 years
measure: Plaque Index (PI)
timeFrame: appoximately 2 years
measure: Gingival Index (GI)
timeFrame: appoximately 2 years
measure: Bleeding on probing (BOP)
timeFrame: appoximately 2 years
measure: Clinical attachment level (CAL)
timeFrame: Patients were seen one time
measure: Probing pocket depth (PD))
timeFrame: appoximately 2 years
Secondary outcomes:
measure: number of individuals with chronic periodontitis
timeFrame: appoximately 2 years
measure: numberer of individuals with polycystic ovary syndrome
timeFrame: appoximately 2 years
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Department of Periodontics, Faculty of Dentistry, Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Eskisehir Osmangazi Üniversitesi
name: Nesrin Saruhan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University
name: Cenk Fatih Çanakcı, Prof
role: STUDY_DIRECTOR
affiliation: Ataturk University
name: Saime Ozbek Sebin, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Buhara Hastanesi
name: Humeyra Canakcı, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University
name: Metin İngeç, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Özel Klinik
name: Ufuk Sezer, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Ebru Saglam, PhD
role: PRINCIPAL_INVESTIGATOR
References: