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PVP Iodine Effect on Post Debridement Bacteraemia

NCT ID: NCT01647347

Last Updated: 2013-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-11-30

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

Conditions

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Bacteraemia Post Debridement

Keywords

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bacteria bacteremia PVP-iodine periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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test treatment

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

Group Type EXPERIMENTAL

Supra- and subgingival rinsing with 10% PVP-iodine

Intervention Type DRUG

rinsing prior to and during subgingival ultrasonic debridement

Control group

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

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

Interventions

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Supra- and subgingival rinsing with 10% PVP-iodine

rinsing prior to and during subgingival ultrasonic debridement

Intervention Type DRUG

Water

Intervention Type OTHER

Other Intervention Names

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Betadine standardized solution (mundipharma, Basel, Switzerland) CH.B. 10070401

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philipp Sahrmann, Senior Assistant

Role: PRINCIPAL_INVESTIGATOR

Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich

Locations

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Clinic for Preventive Dentistry, Perioodntology and Cariology, University of Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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PJB 1

Identifier Type: -

Identifier Source: org_study_id