Periodontal DiseasePhase 2NCT00196456
Photodynamic Lasertherapy (PDT) in Periodontal Treatment (in Vivo)
A Phase 2 study testing photosensitisation in people with Periodontal Disease, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal patients Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- photosensitisation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2004to Jan 2005
- Phase
- Phase 2
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- systemic healthy
- >15 teeth
- ≤ 6 mm >2 teeth
- age > 35 years
Who cannot join
- - systemic ill
- cardiac pacemaker
- < 15 teeth
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, Mecklenburg-Vorpommern, 17489
About this study
The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal patients
Read the detailed description
The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal pockets and to assess the reduction of subgingival bacteria.
The first step will include the evaluation of the quantity of the light which will activate the photosensitizer in the various niches in the periodontal pocket.
The second step will evaluate the distribution of the photosensitizer in the periodontal pocket.
The third step will assess the woundhealing of the the photodynamic therapy compared to conventional periodontal therapy with an ultrasonic device.
- Conditions
- Periodontal Disease
- Being tested
- photosensitisation
- Keywords
- Photodynamic lasertherapy, Periodontol disease
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photosensitisationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pocket depth reduction
Secondary outcomes (1)
attachmentlevel loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Kocher, Prof.Dr., Principal investigator, Ernst-Moritz-Arndt University Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196456
- Sponsor's protocol ID
- III UV 06/04
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Publications
Komerik N, Wilson M, Poole S. The effect of photodynamic action on two virulence factors of gram-negative bacteria. Photochem Photobiol. 2000 Nov;72(5):676-80. doi: 10.1562/0031-8655(2000)0722.0.co;2.
PubMed 11107854
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Lasertherapy (PDT) in Periodontal Treatment (in Vivo)
- ClinicalTrials.gov ID
- NCT00196456
- Acronym / sponsor ID
- III UV 06/04
- Conditions
- Periodontal Disease
- Keywords
- Photodynamic lasertherapy, Periodontol disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Jan 2005
- First posted
- 20 Sep 2005 (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 purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal patients
Detailed description
The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal pockets and to assess the reduction of subgingival bacteria.
The first step will include the evaluation of the quantity of the light which will activate the photosensitizer in the various niches in the periodontal pocket.
The second step will evaluate the distribution of the photosensitizer in the periodontal pocket.
The third step will assess the woundhealing of the the photodynamic therapy compared to conventional periodontal therapy with an ultrasonic device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- systemic healthy
- >15 teeth
- ≤ 6 mm >2 teeth
- age > 35 years
Key exclusion criteria (3 listed)
- - systemic ill
- cardiac pacemaker
- < 15 teeth
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 |
|---|---|---|
| photosensitisation | Procedure or surgery | – |
Primary outcome
pocket depth reduction
1 secondary outcome
attachmentlevel loss
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 20 Sep 2005.
- Background: PubMed 11107854Komerik N, Wilson M, Poole S. The effect of photodynamic action on two virulence factors of gram-negative bacteria. Photochem Photobiol. 2000 Nov;72(5):676-80. doi: 10.1562/0031-8655(2000)0722.0.co;2.
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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.
Thomas Kocher, Prof.Dr. principal investigator
Ernst-Moritz-Arndt University Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing photosensitisation in people with Periodontal Disease, run by University Medicine Greifswald at 1 site in Germany.
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 4 inclusion and 3 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 20 Sep 2005. 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 Germany. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
pocket depth reduction. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00196456, which also lists 1 linked publication.
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 20 Sep 2005.