- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Kontrollera
|
|
Experimentell: Periodontal treatment
The test group received oral hygiene instructions, supragingival and subgingival scaling and root planning using curettes and an ultrasonic appliance.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Reduction in probing depth in sites with PPD>3mm
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UVA71/06
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