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

Primary Purpose

Periodontal Disease

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

photosensitisation

About this trial

This is an interventional treatment trial for Periodontal Disease focused on measuring Photodynamic lasertherapy, Periodontol disease

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: systemic healthy >15 teeth ≤ 6 mm >2 teeth age > 35 years Exclusion Criteria: - systemic ill cardiac pacemaker < 15 teeth

Sites / Locations

Ernst-Moritz-Arndt-Universität Greifswald

Outcomes

Primary Outcome Measures

pocket depth reduction

Secondary Outcome Measures

attachmentlevel loss

Full Information

NCT ID

NCT00196456

First Posted

September 12, 2005

Last Updated

September 12, 2005

Sponsor

University Medicine Greifswald

1. Study Identification

Unique Protocol Identification Number

NCT00196456

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Medicine Greifswald

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

Periodontal Disease

Keywords

Photodynamic lasertherapy, Periodontol disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

photosensitisation

Primary Outcome Measure Information:

Title

pocket depth reduction

Secondary Outcome Measure Information:

Title

attachmentlevel loss

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: systemic healthy >15 teeth ≤ 6 mm >2 teeth age > 35 years Exclusion Criteria: - systemic ill cardiac pacemaker < 15 teeth

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Kocher, Prof.Dr.

Organizational Affiliation

Ernst-Moritz-Arndt University Greifswald

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ernst-Moritz-Arndt-Universität Greifswald

City

Greifswald

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

17489

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

11107854

Citation

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.

Results Reference

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

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