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

Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196456
• Other study ID #: III UV 06/04
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: April 2004
• Est. completion date: January 2005

Study information

• Verified date: September 2005
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal patients

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• systemic healthy

• >15 teeth

• = 6 mm >2 teeth

• age > 35 years

Exclusion Criteria:

• - systemic ill

• cardiac pacemaker

• < 15 teeth

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Procedure:
• photosensitisation

Locations

Country	Name	City	State
Germany	Ernst-Moritz-Arndt-Universität Greifswald	Greifswald	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kömerik 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pocket depth reduction
Secondary	attachmentlevel loss