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PVP Iodine Effect on Post Debridement Bacteraemia (PJB 1)

This study is not yet open for participant recruitment.
Verified March 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01647347
First received: July 16, 2012
Last updated: July 20, 2012
Last verified: March 2012
History of Changes
  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 Blind (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:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    In how many samples a bacterial contamination is found?

  • quality of bacteraemia in central blood stream [ Time Frame: three minutes after starting debridement ] [ Designated as safety issue: No ]
    How many CFU are found in each blood sample?


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647347

Contacts
Contact: Philipp Sahrmann, senior assistant +41 44 63 40481 philipp.sahrmann@zzm.uzh.ch
Contact: Patrick R Schmidlin, Associate professor +41 44 63 43417 patrick.schmidlin@zzm.uzh.ch

Locations
Switzerland
Clinic for Preventive Dentistry, Perioodntology and Cariology, University of Zurich Not yet recruiting
Zurich, ZH, Switzerland, 8032
Contact: Philipp Sahrmann, Senior Assistant     +41 44 63 40481     philipp.sahrmann@zzm.uzh.ch    
Contact: Patrick R Schmidlin, Assiociate Professor     +41 44 63 43417     patrick.schmidlin@zzm.uzh.ch    
Principal Investigator: Philipp Sahrmann, Senior Assistant            
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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01647347     History of Changes
Other Study ID Numbers: PJB 1
Study First Received: July 16, 2012
Last Updated: July 20, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
bacteraemia
periodontitis
PVP-iodine
antiseptics

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
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013