PVP Iodine Effect on Post Debridement Bacteraemia

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Bacteraemia Post Debridement

Intervention / Treatment
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* Drug: Supra- and subgingival rinsing with 10% PVP-iodine
* Other: Water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test treatment<br>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<br>* rinsing prior to and during subgingival ultrasonic debridement<br>* Other names: CH.B. 10070401;|
| Placebo Comparator: Control group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacteria, bacteremia, PVP-iodine, periodontitis