Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

PerioWave Re-Treatment Protocol Compared to Scaling and Root Planing (SRP) and a Single Treatment With PerioWave

Lead Sponsor:

Ondine Research Laboratories

Collaborating Sponsors:

Loma Linda University

Conditions:

Periodontitis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

This is a pivotal, prospective, randomized, blinded, multicenter study to evaluate two treatments of photodynamic disinfection in adults with chronic periodontal disease. The study is expected to enro...

Detailed Description

The key question is whether scaling and root planing (SRP) followed by one or two doses of photodynamic disinfection using 0.01% MB result in improved outcomes that persist over time in adults with ch...

Eligibility Criteria

Inclusion

  • The subject is capable of giving informed consent
  • The subject is willing to sign a consent form
  • The subject is an adult male or female \> 18
  • The subject is diagnosed with chronic periodontitis
  • The subject has \>18 fully erupted teeth
  • The subject has at least 4 measurement sites with pocket depth of 6-9 mm in at least two quadrants of the mouth.
  • Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study

Exclusion

  • The subject is pregnant or nursing or who plans to become pregnant in the next 4 months
  • The subject has significant liver disease by subject report
  • The subject has an active malignancy of any type by subject report
  • The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
  • The subject has any significant disease (either acute or chronic) or who is taking a medication with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of PERIOWAVE®
  • The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis
  • The subject has been treated with antibiotics within the 1-month period prior to beginning the study or any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements, etc.) by report of the subject
  • The subject has a known allergy to Methylene Blue
  • Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
  • The subject currently uses anti-coagulant therapy at therapeutic doses
  • The subject is currently using any photosensitizing medications
  • The subject has participated in investigational treatment in the last 30 days or has the expectation for using a separate investigational treatment during the time of the study

Key Trial Info

Start Date :

January 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2006

Estimated Enrollment :

105 Patients enrolled

Trial Details

Trial ID

NCT00336661

Start Date

January 1 2006

End Date

December 1 2006

Last Update

May 21 2007

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

Shanghai Second Medical University

Shanghai, China

2

Wenzhou Hospital Department of Dentistry

Wenzhou, China