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PVP Iodine Effect on Post Debridement Bacteraemia (PJB 1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01647347
First Posted: July 23, 2012
Last Update Posted: December 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose

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.


Condition Intervention Phase
Bacteraemia Post Debridement Drug: Supra- and subgingival rinsing with 10% PVP-iodine Other: Water Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Ultrasonic Debridement With PVP-iodine Irrigation on Post-treatment Bacteraemia Compared to Ultrasonic Debridement With Water

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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?


Enrollment: 20
Study Start Date: August 2012
Study Completion Date: November 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Supra- and subgingival rinsing with 10% PVP-iodine
rinsing prior to and during subgingival ultrasonic debridement
Other Names:
  • Betadine standardized solution (mundipharma, Basel, Switzerland)
  • CH.B. 10070401
Placebo Comparator: 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
Other: Water

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647347


Locations
Switzerland
Clinic for Preventive Dentistry, Perioodntology and Cariology, University of Zurich
Zurich, ZH, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Philipp Sahrmann, Senior Assistant Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01647347     History of Changes
Other Study ID Numbers: PJB 1
First Submitted: July 16, 2012
First Posted: July 23, 2012
Last Update Posted: December 23, 2013
Last Verified: December 2013

Keywords provided by University of Zurich:
bacteria
bacteremia
PVP-iodine
periodontitis

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Iodine
Cadexomer iodine
Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs