Study of Scaling and Root Planing (SRP) With PerioWave vs. SRP Alone in Chronic Periodontitis

NCT00297518 | Completed Phase 4

• 1 other identifier: ORL-0605-5
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to determine whether scaling and root planning (SRP) followed by photodynamic disinfection results in improved outcomes that persist over time in adults with chronic periodontitis when compared with subjects with SRP alone.

Conditions

Periodontitis

Keywords

Adult Periodontitis; Chronic Periodontitis; PDD; PDT; Photodynamic Disinfection; SRP; Scaling and Root Planing

Outcome Measures

Primary Outcomes (1)

• Increase in Clinical Attachment Level

  6, 12 weeks

Secondary Outcomes (2)

• Reduction in Periodontal Pocket Depth

  6, 12 weeks

• Reduction in Bleeding on Probing

  6, 12 weeks

Interventions

PerioWave DEVICE

Scaling and Root Planing PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• The subject has smoked tobacco products in the last year

Sponsors & Collaborators

• Ondine Research Laboratories: lead

Study Sites (2)

Office of Dr. Sonia Leziy

North Vancouver, British Columbia, Canada

Location

University of British Columbia School of Dentistry

Vancouver, British Columbia, Canada

Location

Related Publications (43)

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MeSH Terms

Conditions

Periodontitis; Chronic Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Edward Putnins, DDS

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Study Start: March 1, 2006
• Study Completion: January 1, 2007
• Last Updated: May 21, 2007

Record last verified: 2007-05

Locations

CA (2)