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Clinical Trials/NCT01647347
NCT01647347
Completed
Phase 4

Effects of Ultrasonic Debridement With PVP-iodine Irrigation on Post-treatment Bacteraemia Compared to Ultrasonic Debridement With Water

University of Zurich1 site in 1 country20 target enrollmentAugust 2012

Overview

Phase
Phase 4
Intervention
Supra- and subgingival rinsing with 10% PVP-iodine
Conditions
Bacteraemia Post Debridement
Sponsor
University of Zurich
Enrollment
20
Locations
1
Primary Endpoint
quantity of bacteraemia in central blood stream
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The study investigates the effect of supra- and subgingival rinsing of 10% PVP prior to ultrasonic debridement in patients with periodontitis (as compared to rinsing with water) in terms of post treatment bacteraemia.

Study design: Randomized split-mouth (cross-over) study on 20 generally healthy subjects.

Detailed Description

Process: Test treatment: * 1 min mouthwash with 10% PVP-iodine * 1 min subgingival rinsing with 10% PVP-iodine * 1 min ultrasonic debridement with 10% PVP-iodine as cooling liquid * blood sampling from the V.mediana cupidi Control: * 1 min mouthwash with water * 1 min subgingival rinsing with water * 1 min ultrasonic debridement with water as cooling liquid * blood sampling from the V.mediana cupidi lysis, culturing and analysis of bacteria in the samples

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
November 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • generally healthy, adult (≥ 18 years) patients with at least two periodontal pockets of ≥ 5 mm

Exclusion Criteria

  • Pregnancy
  • Lactation
  • Allergy on PVP-iodine
  • anticoagulation (exception 100mg/d acetylsalicylic acid)
  • high risc for endocarditis
  • therapeutical radiation
  • participation in other clinical studies
  • cognitive impairment (patient unable to understand aim and conduction of the study

Arms & Interventions

test treatment

Test treatment: * 1 min mouthwash with 10% PVP-iodine * 1 min subgingival rinsing with 10% PVP-iodine * 1 min ultrasonic debridement with 10% PVP-iodine as cooling liquid * blood sampling from the V.mediana cupidi

Intervention: Supra- and subgingival rinsing with 10% PVP-iodine

Control group

Control: * 1 min mouthwash with water * 1 min subgingival rinsing with water * 1 min ultrasonic debridement with water as cooling liquid * blood sampling from the V.mediana cupidi

Intervention: Water

Outcomes

Primary Outcomes

quantity of bacteraemia in central blood stream

Time Frame: three minutes after starting debridement

In how many samples a bacterial contamination is found?

quality of bacteraemia in central blood stream

Time Frame: three minutes after starting debridement

How many CFU are found in each blood sample?

Study Sites (1)

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