PVP Iodine Effect on Post Debridement Bacteraemia (PJB 1)

December 20, 2013 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8032
        • Clinic for Preventive Dentistry, Perioodntology and Cariology, University of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantity of bacteraemia in central blood stream
Time Frame: three minutes after starting debridement
In how many samples a bacterial contamination is found?
three minutes after starting debridement
quality of bacteraemia in central blood stream
Time Frame: three minutes after starting debridement
How many CFU are found in each blood sample?
three minutes after starting debridement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Philipp Sahrmann, Senior Assistant, Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 20, 2012

First Posted (Estimate)

July 23, 2012

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJB 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bacteraemia Post Debridement

Clinical Trials on Water

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe