PVP Iodine Effect on Post Debridement Bacteraemia (PJB 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01647347
First received: July 16, 2012
Last updated: December 20, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
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:


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?


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: December 20, 2013
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on October 29, 2014