- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01475435
Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients
16. november 2011 opdateret af: Luiz Antonio Pugliesi Alves de Lima, University of Sao Paulo
Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients With Generalized Chronic Periodontitis and Healthy Periodontium
Abstract Diabetes mellitus and periodontal diseases are both chronic inflammatory disorders that have a major impact on the health and well being of millions of individuals worldwide.
Periodontal diseases are among the most common diseases in humans, therefore, if the presence of periodontal diseases plays any role in overall systemic health, the public health impact may be substantial.
An important factor that can be involved in the progression of the periodontal disease is the production of Reactive Oxygen Species (ROS).
The imbalance between oxidative stress induced by ROS and the concentrations (or activity) of the antioxidant may result in tissue damage.
The ROS induce the activity of lipid peroxidation-Tbars, myeloperoxidase (MPO), peroxidase and arginase, whose mechanisms reflect the severity of the periodontal disease and it may offer the basis for a patient specific diagnostic test for periodontitis and could have therapeutic significance.
The aim of this study is to investigate quantitatively the levels of oxidative stress markers (Myeloperoxidase, Peroxidase, Lipid Peroxidation and Arginase) in saliva and in gingival crevicular fluid (GCF) of diabetes type 2 subjects with generalized chronic periodontitis and periodontally healthy individuals, and systematically healthy individuals with generalized chronic periodontitis and periodontally healthy individuals, before and after periodontal treatment.
Unstimulated whole saliva will be collected for 5 min as well as GCF of 25 diabetes type 2 with generalized chronic periodontitis, 25 diabetes type 2 periodontally healthy individuals as controls, 25 systematically healthy individuals with generalized chronic periodontitis and 25 periodontally healthy individuals before and after treatment.
The following clinical parameters will be evaluated: probing pocket depth, probing attachment level, plaque index and the gingival index.
The activity of stress markers in saliva and GFC will be analyzed by spectrophotometry.
Adequate statistical analysis will be carried out with a p-value set at p < 0.05.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
200
Fase
- Tidlig fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
SP
-
São Paulo, SP, Brasilien, 05508-000
- Rekruttering
- University of Sao Paulo
-
Kontakt:
- Luiz Antônio Pugliesi Alves de Lima, PhD
- Telefonnummer: 55-11-30917833
- E-mail: lapalima@usp.br
-
Kontakt:
- Ana Paula Sassá Benedete
- Telefonnummer: 55-11-30917833
- E-mail: abenedete@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with type 2 diabetes and chronic periodontitis(more than 30% of the sites involved, AAP, 1999)
- Patients with type 2 diabetes and periodontally healthy (AAP, 1999)
- Patients systemically healthy with chronic periodontitis (more than 30% of the sites involved)
- Patients systemically and periodontally healthy
- Patients with at least 15 natural teeth (excluding 3rd molars).
- At least 30% of sites with probing pocket depth (PD)> 5 mm and a maximum of 60% sites with PS <7 mm
- Clinical attachment level (CAL)> 4 mm
- Visible plaque and bleeding on probing (BOP)
- Patients with type 2 diabetes have to bear the disease for at least five years and have to show a blood percentage of glycated hemoglobin between 6.5% to 8% (UKPDS 1998) at baseline
Exclusion Criteria
- Individuals with periodontal pockets deeper than 7 mm
- Patients with any other systemic disease (except diabetes type 2)
- Patients who have used medications such as anticoagulants, contraceptives or antidepressants in the past 6 months
- Patients who have used antibiotic and anti-inflammatory drugs in the last 3 months before the of the study
- Smoking
- Pregnancy
- Patients who have received periodontal treatment in the last six months before the start of this study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: chronic periodontitis
Saliva and GCF samples will be evaluated before and after treatment from patients treated of chronic periodontitis.
|
scaling and root planning
|
Placebo komparator: periodontally healthy individuals
Saliva and GCF samples will be evaluated from periodontally healthy individuals at baseline.
|
Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
|
Aktiv komparator: chronic periodontitis with diabetes type 2
Saliva and GCF samples will be evaluated before and after treatment from patients with diabetes type 2 treated of chronic periodontitis
|
scaling and root planning
|
Placebo komparator: periodontally healthy individuals with diabetes type 2
Saliva and GCF samples will be evaluated from periodontally healthy individuals with diabetes type 2 at baseline
|
Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Evaluate level change of oxidative stress biomarkers in crevicular gingival fluid and whole saliva on diabetes type 2 individuals
Tidsramme: baseline and 4 weeks after periodontal treatment
|
The participants will be followed for an expected average of 4 weeks after periodontal treatment.
The samples of saliva and crevicular gingival fluid will be evaluated at baseline and four weeks after periodontal treatment.
|
baseline and 4 weeks after periodontal treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Luiz A Lima, PhD, University of Sao Paulo
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2011
Primær færdiggørelse (Forventet)
1. december 2011
Studieafslutning (Forventet)
1. august 2013
Datoer for studieregistrering
Først indsendt
22. august 2011
Først indsendt, der opfyldte QC-kriterier
16. november 2011
Først opslået (Skøn)
21. november 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. november 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. november 2011
Sidst verificeret
1. august 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DMSAL2712
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Diabetes mellitus type 2
-
University Hospital Inselspital, BerneAfsluttetType 2 diabetes mellitusSchweiz
-
India Diabetes Research Foundation & Dr. A. Ramachandran...Afsluttet
-
AstraZenecaRekruttering
-
Daewoong Pharmaceutical Co. LTD.Ikke rekrutterer endnuT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRekrutteringType 2 diabetes mellitus (T2DM)Kina
-
Newsoara Biopharma Co., Ltd.RekrutteringT2DM (Type 2 Diabetes Mellitus)Kina
-
Shanghai Golden Leaf MedTec Co. LtdAktiv, ikke rekrutterendeType 2 diabetes mellitus (T2DM)Kina
-
SanofiAfsluttet
-
Haisco Pharmaceutical Group Co., Ltd.AfsluttetT2DM (Type 2 Diabetes Mellitus)Kina
-
PegBio Co., Ltd.AfsluttetType 2 diabetes mellitus (T2DM)Kina
Kliniske forsøg med non- surgical periodontal treatment
-
Hartford HospitalAstellas Pharma IncAfsluttetProlaps af bækkenorganerForenede Stater
-
Assistance Publique - Hôpitaux de ParisAfsluttetIdiopatisk Membranøs NefropatiFrankrig