PVP Iodine Effect on Post Debridement Bacteraemia (PJB 1)

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Bacteraemia Post Debridement

Treatments: Other: Water; Drug: Supra- and subgingival rinsing with 10% PVP-iodine

Study type: Interventional

Funder types: Other

Identifiers

NCT01647347

PJB 1

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

test treatment

Experimental group

Description:

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

Treatment:

Drug: Supra- and subgingival rinsing with 10% PVP-iodine

Control group

Placebo Comparator group

Description:

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

Treatment:

Other: Water