PVP Iodine Effect on Post Debridement Bacteraemia

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01647347

Acronym

PJB 1

Enrollment

Registered

2012-07-23

Start date

2012-08-31

Completion date

2013-11-30

Last updated

2013-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteraemia Post Debridement

Keywords

bacteria, bacteremia, PVP-iodine, periodontitis

Brief summary

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.

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

Interventions

DRUGSupra- and subgingival rinsing with 10% PVP-iodine

rinsing prior to and during subgingival ultrasonic debridement

OTHERWater

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026