PVP Iodine Effect on Post Debridement Bacteraemia

Phase 4

Completed

• Conditions: Bacteraemia Post Debridement
• Interventions: Drug: Supra- and subgingival rinsing with 10% PVP-iodine; Other: Water

• Registration Number: NCT01647347
• Lead Sponsor: University of Zurich

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-23
• Study Start: 2012-08
• Primary Completion: 2013-07
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-20
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• generally healthy, adult (≥ 18 years) patients with at least two periodontal pockets of ≥ 5 mm

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
test treatment	Supra- and subgingival rinsing with 10% PVP-iodine	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 group	Water	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

Primary Outcome Measures

Name	Time	Method
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?

Trial Locations

Locations (1)

Clinic for Preventive Dentistry, Perioodntology and Cariology, University of Zurich; 🇨🇭 Zurich, ZH, Switzerland