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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02954120
Other study ID # PCOSandCP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2013
Est. completion date September 2015

Study information

Verified date January 2020
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date September 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

Other:
no intervention provided


Locations

Country Name City State
Turkey Department of Periodontics, Faculty of Dentistry, Bezmialem Vakif University Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 8-OHdG levels (nanogram per mililiter(ng/mL)) by ELISA test appoximately 2 years
Primary MDA levels (micromole per liter (µmol/L)) by ELISA test appoximately 2 years
Primary TAS levels (millimolar per liter (mmol /L)) by ELISA test appoximately 2 years
Primary Plaque Index (PI) Silnes-Löe Periodondal Index appoximately 2 years
Primary Gingival Index (GI) Löe-Silness Periodontal Index appoximately 2 years
Primary Bleeding on probing (BOP) GIngival Bleeding Index appoximately 2 years
Primary Clinical attachment level (CAL) by measuring the distance between the cementoenamel junction and the periodontal pocket base Patients were seen one time
Primary Probing pocket depth (PD)) distance between free gingival margin and periodontal pocket base by usin periodontal probe appoximately 2 years
Secondary number of individuals with chronic periodontitis individuals in the group appoximately 2 years
Secondary numberer of individuals with polycystic ovary syndrome individuals in the group appoximately 2 years
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