Bacteraemia Post DebridementPhase 4PJB 1NCT01647347
PVP Iodine Effect on Post Debridement Bacteraemia
A Phase 4 study testing Supra- and subgingival rinsing with 10% PVP-iodine and Water in people with Bacteraemia Post Debridement, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacteraemia Post Debridement
- What is being tested?
- Supra- and subgingival rinsing with 10% PVP-iodine and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2012to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generally healthy, adult (≥ 18 years) patients with at least two periodontal pockets of ≥ 5 mm
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Preventive Dentistry, Perioodntology and Cariology, University of Zurich
Zurich, Canton of Zurich, 8032
About this study
Official title: Effects of Ultrasonic Debridement With PVP-iodine Irrigation on Post-treatment Bacteraemia Compared to Ultrasonic Debridement With Water
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.
Read the 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
- Conditions
- Bacteraemia Post Debridement
- Being tested
- Supra- and subgingival rinsing with 10% PVP-iodine, Water
- Keywords
- bacteria, bacteremia, PVP-iodine, periodontitis
- Medical subject headings
- Bacteremia, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supra- and subgingival rinsing with 10% PVP-iodineDrug
Also called Betadine standardized solution (mundipharma, Basel, Switzerland), CH.B. 10070401
rinsing prior to and during subgingival ultrasonic debridement
WaterOther
| Study group | Role | What they receive |
|---|---|---|
| test treatment | Experimental | 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 Receives: Drug: Supra- and subgingival rinsing with 10% PVP-iodine |
| Control group | Placebo comparator | 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 Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantity of bacteraemia in central blood stream
In how many samples a bacterial contamination is found?
Measured: three minutes after starting debridement
quality of bacteraemia in central blood stream
How many CFU are found in each blood sample?
Measured: three minutes after starting debridement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteraemia Post DebridementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Sahrmann, Senior Assistant, Principal investigator, Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647347
- Sponsor's protocol ID
- PJB 1
- Acronym
- PJB 1
- Status last verified
- Dec 2013
- First submitted
- 16 Jul 2012
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasonic Debridement With PVP-iodine Irrigation on Post-treatment Bacteraemia Compared to Ultrasonic Debridement With Water
- ClinicalTrials.gov ID
- NCT01647347
- Acronym / sponsor ID
- PJB 1 / PJB 1
- Conditions
- Bacteraemia Post Debridement
- Keywords
- bacteria, bacteremia, PVP-iodine, periodontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test treatment | Experimental | Drug: Supra- and subgingival rinsing with 10% PVP-iodineTest 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 | Placebo comparator | Other: WaterControl: * 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- generally healthy, adult (≥ 18 years) patients with at least two periodontal pockets of ≥ 5 mm
Key exclusion criteria (8 listed)
- Pregnancy
- Lactation
- Allergy on PVP-iodine
- anticoagulation (exception 100mg/d acetylsalicylic acid)
- high risc for endocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supra- and subgingival rinsing with 10% PVP-iodineAlso: Betadine standardized solution (mundipharma, Basel, Switzerland), CH.B. 10070401rinsing prior to and during subgingival ultrasonic debridement | Drug | test treatment |
| Water | Other | Control group |
Primary outcome
quantity of bacteraemia in central blood stream
Time frame: three minutes after starting debridement
In how many samples a bacterial contamination is found?
quality of bacteraemia in central blood stream
Time frame: three minutes after starting debridement
How many CFU are found in each blood sample?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Sahrmann, Senior Assistant principal investigator
Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Supra- and subgingival rinsing with 10% PVP-iodine and Water in people with Bacteraemia Post Debridement, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantity of bacteraemia in central blood stream (time frame: three minutes after starting debridement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2013.