Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients
16. november 2011 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
200
Fase
- Tidlig fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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SP
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São Paulo, SP, Brasil, 05508-000
- Rekruttering
- University of Sao Paulo
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Ta kontakt med:
- Luiz Antônio Pugliesi Alves de Lima, PhD
- Telefonnummer: 55-11-30917833
- E-post: lapalima@usp.br
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Ta kontakt med:
- Ana Paula Sassá Benedete
- Telefonnummer: 55-11-30917833
- E-post: abenedete@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: chronic periodontitis
Saliva and GCF samples will be evaluated before and after treatment from patients treated of chronic periodontitis.
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scaling and root planning
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Placebo komparator: periodontally healthy individuals
Saliva and GCF samples will be evaluated from periodontally healthy individuals at baseline.
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Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
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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
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scaling and root planning
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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
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Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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.
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baseline and 4 weeks after periodontal treatment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Luiz A Lima, PhD, University of Sao Paulo
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2011
Primær fullføring (Forventet)
1. desember 2011
Studiet fullført (Forventet)
1. august 2013
Datoer for studieregistrering
Først innsendt
22. august 2011
Først innsendt som oppfylte QC-kriteriene
16. november 2011
Først lagt ut (Anslag)
21. november 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. november 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. november 2011
Sist bekreftet
1. august 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DMSAL2712
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