PVP Iodine Effect on Post Debridement Bacteraemia

Bacteraemia Post Debridement Clinical Trial

— PJB 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647347
• Other study ID #: PJB 1
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2012
• Last updated: December 20, 2013
• Start date: August 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteraemia Post Debridement
• Bacteremia

Intervention

Drug:
• Supra- and subgingival rinsing with 10% PVP-iodine
rinsing prior to and during subgingival ultrasonic debridement

Other:
• Water

Locations

Country	Name	City	State
Switzerland	Clinic for Preventive Dentistry, Perioodntology and Cariology, University of Zurich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantity of bacteraemia in central blood stream	In how many samples a bacterial contamination is found?	three minutes after starting debridement	No
Primary	quality of bacteraemia in central blood stream	How many CFU are found in each blood sample?	three minutes after starting debridement	No