Photodynamic Lasertherapy (PDT) in Periodontal Treatment... | NCT00196456

Studies
Photodynamic Lasertherapy (PDT) in Periodontal Treatment (in Vivo)

NCT00196456

Sponsor

University Medicine Greifswald

Status

Completed

Last Update Posted

Sep 20, 2005Estimated

Enrollment

Phase

Phase 2

Conditions

Periodontal Disease

Interventions

photosensitisation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Not provided

Completion Date

Jan 2005

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2005

Last Update Posted Date

Sep 20, 2005Estimated

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
photosensitisation	Procedure

Measure	Description	Time Frame
pocket depth reduction

Measure	Description	Time Frame
attachmentlevel loss

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

systemic healthy
>15 teeth
≤ 6 mm >2 teeth
age > 35 years

Exclusion Criteria:

- systemic ill
cardiac pacemaker
< 15 teeth

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Kocher, Prof.Dr.	Ernst-Moritz-Arndt University Greifswald	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ernst-Moritz-Arndt-Universität Greifswald		Greifswald	Mecklenburg-Vorpommern	17489	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11107854	Background	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.

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases