- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Fatih
-
İstanbul, Fatih, Tacchino, 34093
- Department of Periodontics, Faculty of Dentistry, Bezmialem Vakif University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Trasversale
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
(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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
8-OHdG levels (nanogram per mililiter(ng/mL))
Lasso di tempo: appoximately 2 years
|
by ELISA test
|
appoximately 2 years
|
MDA levels (micromole per liter (µmol/L))
Lasso di tempo: appoximately 2 years
|
by ELISA test
|
appoximately 2 years
|
TAS levels (millimolar per liter (mmol /L))
Lasso di tempo: appoximately 2 years
|
by ELISA test
|
appoximately 2 years
|
Plaque Index (PI)
Lasso di tempo: appoximately 2 years
|
Silnes-Löe Periodondal İndex
|
appoximately 2 years
|
Gingival Index (GI)
Lasso di tempo: appoximately 2 years
|
Löe-Silness Periodontal Index
|
appoximately 2 years
|
Bleeding on probing (BOP)
Lasso di tempo: appoximately 2 years
|
Gİngival Bleeding Index
|
appoximately 2 years
|
Clinical attachment level (CAL)
Lasso di tempo: 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))
Lasso di tempo: appoximately 2 years
|
distance between free gingival margin and periodontal pocket base by usin periodontal probe
|
appoximately 2 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
number of individuals with chronic periodontitis
Lasso di tempo: appoximately 2 years
|
individuals in the group
|
appoximately 2 years
|
numberer of individuals with polycystic ovary syndrome
Lasso di tempo: appoximately 2 years
|
individuals in the group
|
appoximately 2 years
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nesrin Saruhan, PhD, Eskisehir Osmangazi Universitesi
- Direttore dello studio: Cenk Fatih Çanakcı, Prof, Atatürk Üniversitesi
- Investigatore principale: Saime Ozbek Sebin, Dr, Atatürk Üniversitesi
- Investigatore principale: Humeyra Canakcı, Dr, Buhara Hastanesi
- Investigatore principale: Metin İngeç, Prof, Atatürk Üniversitesi
- Investigatore principale: Ufuk Sezer, Phd, Özel Klinik
- Investigatore principale: Ebru Saglam, PhD, Saglik Bilimleri Universitesi
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PCOSandCP
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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