Chronic Periodontitis and Polycystic Ovary Syndrome

NCT02954120 | Completed DMC

• 1 other identifier: PCOSandCP
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Chronic Periodontitis

Keywords

8- hydroxy -2´- deoxyguanosine; Malondialdehyde; Total antioxidant status; Oxidative stres

Outcome Measures

Primary Outcomes (8)

• 8-OHdG levels (nanogram per mililiter(ng/mL))

  by ELISA test

  appoximately 2 years

• MDA levels (micromole per liter (µmol/L))

  by ELISA test

  appoximately 2 years

• TAS levels (millimolar per liter (mmol /L))

  by ELISA test

  appoximately 2 years

• Plaque Index (PI)

  Silnes-Löe Periodondal İndex

  appoximately 2 years

• Gingival Index (GI)

  Löe-Silness Periodontal Index

  appoximately 2 years

• Bleeding on probing (BOP)

  Gİngival Bleeding Index

  appoximately 2 years

• Clinical attachment level (CAL)

  by measuring the distance between the cementoenamel junction and the periodontal pocket base

  Patients were seen one time

• Probing pocket depth (PD))

  distance between free gingival margin and periodontal pocket base by usin periodontal probe

  appoximately 2 years

Secondary Outcomes (2)

• number of individuals with chronic periodontitis

  appoximately 2 years

• numberer of individuals with polycystic ovary syndrome

  appoximately 2 years

Study Arms (4)

(PCOS-CP-)

systemically and periodontally healthy participants

Other: no intervention provided

(PCOS-CP+)

systemically healthy participants with CP

Other: no intervention provided

(PCOS+CP-)

PCOS participants with periodontally healthy

Other: no intervention provided

(PCOS+CP+)

PCOS participants with CP

Other: no intervention provided

Interventions

no intervention provided OTHER

(PCOS+CP+); (PCOS+CP-); (PCOS-CP+); (PCOS-CP-)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Newly diagnosed non-obese PCOS patients
• Never smokers
• Had no history of systemic disease
• BMI\<25 kg/m2
• Participants had ≥20 teeth present.

You may not qualify if:

• Pregnancy
• Lactation
• Hemoglobin A1c (HbA1c) ≥ 6.5%
• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Department of Periodontics, Faculty of Dentistry, Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and saliva samples were obtained and stored until biochemical analyses

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nesrin Saruhan, PhD

  Eskisehir Osmangazi Üniversitesi

  PRINCIPAL INVESTIGATOR

• Cenk Fatih Çanakcı, Prof

  Ataturk University

  STUDY DIRECTOR

• Saime Ozbek Sebin, Dr

  Ataturk University

  PRINCIPAL INVESTIGATOR

• Humeyra Canakcı, Dr

  Buhara Hastanesi

  PRINCIPAL INVESTIGATOR

• Metin İngeç, Prof

  Ataturk University

  PRINCIPAL INVESTIGATOR

• Ufuk Sezer, Phd

  Özel Klinik

  PRINCIPAL INVESTIGATOR

• Ebru Saglam, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 3, 2016
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

TU (1)