- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02150005
Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles in Patients With Coronariopathies
Effects of Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles of Patients With an Indication for Surgical Coronary Revascularization
Objective: The aim of this study was to examine the effects of non-surgical periodontal treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an indication for surgical revascularization.
Materials and Methods: Twenty-two patients with chronic periodontitis, over 35 years of age (mean age 59.45 years) randomly assigned into 2 groups were evaluated. Test group (n=11), received periodontal treatment before the surgical procedure, and control group (n=11), did not received periodontal treatment prior to surgery.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Undergoing cardiovascular treatment;
- Eight viable teeth in the oral cavity;
- Four periodontal sites with periodontal probing depths ≥5mm in different teeth.
Exclusion Criteria:
-
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Styre
|
|
Eksperimentell: Periodontal treatment
The test group received oral hygiene instructions, supragingival and subgingival scaling and root planning using curettes and an ultrasonic appliance.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Reduction in probing depth in sites with PPD>3mm
Tidsramme: Baseline and 90 days after the initial exam
|
Reduction of 11.4% in probing depth in sites with Periodontal Probing Depth>3mm
|
Baseline and 90 days after the initial exam
|
Reduction in probing depth in sites with PPD>5mm
Tidsramme: Baseline and 90 days after the initial exam
|
Reduction of 6.3% in probing depth in sites with Periodontal Probing Depth>5mm
|
Baseline and 90 days after the initial exam
|
Reduction in probing depth in sites with CAL>3mm
Tidsramme: Baseline and 90 days after the initial exam
|
Reduction of 4.6% in probing depth in sites with Clinical Attachment Level >3mm.
|
Baseline and 90 days after the initial exam
|
Reduction in probing depth in sites with CAL >5mm
Tidsramme: Baseline and 90 days after the initial exam
|
Reduction of 3.6% in probing depth in sites with Clinical Attachment Level >5mm.
|
Baseline and 90 days after the initial exam
|
Leukocyte count
Tidsramme: Baseline and 90 days after the initial exam
|
Non-significant reduction of leukocyte count in the test group.
Mean difference of 74.6 m/mcL.
|
Baseline and 90 days after the initial exam
|
Glucose
Tidsramme: Baseline and 90 days after the initial exam
|
Glucose showed a non-significant increase in the test group.
Mean difference of 24.2 mg/dL.
|
Baseline and 90 days after the initial exam
|
Hemocyte
Tidsramme: Baseline and 90 days after initial exam
|
Hemocyte presented a non-significant reduction in the test group.
Mean difference 0.39 m/mcL
|
Baseline and 90 days after initial exam
|
Hemoglobin
Tidsramme: Baseline and 90 days after initial exam
|
Non-significant reduction in test group.
Mean difference of 0.2 g/dL
|
Baseline and 90 days after initial exam
|
Total Cholesterol
Tidsramme: Baseline and 90 days after initial exam
|
Significant reduction in the test group.
Mean reduction of 27.4 mg/dL.
|
Baseline and 90 days after initial exam
|
High density lipid
Tidsramme: Baseline and 90 days after initial exam
|
Significant reduction in test group.
Mean difference of 8.2 mg/dL.
|
Baseline and 90 days after initial exam
|
Low density lipid
Tidsramme: Baseline and 90 days after initial exam
|
Non-significant reduction in test group.
Mean difference of 8.9 mg/dL.
|
Baseline and 90 days after initial exam
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UVA71/06
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