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PVP Iodine Effect on Post Debridement Bacteraemia (PJB 1)

Primary Purpose

Bacteraemia Post Debridement

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Supra- and subgingival rinsing with 10% PVP-iodine

Water

About this trial

This is an interventional prevention trial for Bacteraemia Post Debridement focused on measuring bacteria, bacteremia, PVP-iodine, periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

test treatment

Control group

Arm 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

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

Outcomes

Primary Outcome Measures

quantity of bacteraemia in central blood stream

In how many samples a bacterial contamination is found?

quality of bacteraemia in central blood stream

How many CFU are found in each blood sample?

Secondary Outcome Measures

Full Information

NCT ID

NCT01647347

First Posted

July 16, 2012

Last Updated

December 20, 2013

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT01647347

Brief Title

PVP Iodine Effect on Post Debridement Bacteraemia

Acronym

PJB 1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacteraemia Post Debridement

Keywords

bacteria, bacteremia, PVP-iodine, periodontitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

test treatment

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm 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

Intervention Type

Drug

Intervention Name(s)

Supra- and subgingival rinsing with 10% PVP-iodine

Other Intervention Name(s)

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

Intervention Description

rinsing prior to and during subgingival ultrasonic debridement

Intervention Type

Other

Intervention Name(s)

Water

Primary Outcome Measure Information:

Title

quantity of bacteraemia in central blood stream

Description

In how many samples a bacterial contamination is found?

Time Frame

three minutes after starting debridement

Title

quality of bacteraemia in central blood stream

Description

How many CFU are found in each blood sample?

Time Frame

three minutes after starting debridement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philipp Sahrmann, Senior Assistant

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Zurich

State/Province

ZIP/Postal Code

8032

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

PVP Iodine Effect on Post Debridement Bacteraemia

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