Skip to main content
OpenTrials
Completed

NCT Number: NCT01647347

PVP Iodine Effect on Post Debridement Bacteraemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacteraemia Post Debridement Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Sepsis Stomatognathic Diseases Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinic for Preventive Dentistry, Perioodntology and Cariology, University of Zurich

Zurich, Canton of Zurich, 8032, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supra- and subgingival rinsing with 10% PVP-iodine

Drug

rinsing prior to and during subgingival ultrasonic debridement

Other names: Betadine standardized solution (mundipharma, Basel, Switzerland), CH.B. 10070401

Water

Other

Primary outcomes

  1. quantity of bacteraemia in central blood stream

    Time frame: three minutes after starting debridement

    In how many samples a bacterial contamination is found?

  2. quality of bacteraemia in central blood stream

    Time frame: three minutes after starting debridement

    How many CFU are found in each blood sample?

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: PJB 1

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 23, 2012
Registry last updated
Dec 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.