Study of Scaling and Root Planing With PerioWave Versus Scaling and Root Planing Alone in Chronic Periodontitis

Periodontitis Clinical Trial

Official title:

Photodynamic Disinfection in Combination With Scaling and Root Planing in the Treatment of Chronic Periodontitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00297531
• Other study ID #: ORL-0605-4
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 24, 2006
• Last updated: May 17, 2007
• Start date: April 2006
• Est. completion date: October 2007

Study information

• Verified date: May 2007
• Source: Ondine Research Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

This study is to determine whether scaling and root planing (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.

Description:

Extensive research has shown that lethal photosensitization with low levels of laser light is an effective method of killing numerous types of organisms. This therapy avoids the use of antibiotics along with their potential side effects. The initial application of this therapy to the oral cavity is particularly appropriate since the therapy can be applied topically either in a specific or general fashion, killing is immediate and resistance is unlikely as it is free radical-mediated. In addition, the disease states being treated (gingivitis & periodontitis) are highly prevalent and associated with significant morbidity. The equipment and costs of this therapy are simple, easily applied and relatively inexpensive compared with current therapies. Based on the scientific data to date this therapy has the potential of significantly improving the oral health of those affected.

This is a pivotal, prospective, randomized, examiner blinded, multicenter study to evaluate the effect of a single treatment of photodynamic disinfection in adults with chronic periodontal disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult male or female over the age of 18

2. Having been diagnosed with chronic periodontitis

3. >18 fully erupted teeth

4. Has had no periodontal instrumentation in the four months prior to initiation of study treatment

5. Subject has at least 4 sites with pocket depth of 6-9 mm in at least two quadrants of the mouth.

6. Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study

7. The subject is capable of giving informed consent

8. Subject is willing to sign a consent form

Exclusion Criteria:

1. Is pregnant or nursing or who plans to become pregnant in the next 4 months

2. Having significant liver disease by subject report

3. Having an active malignancy of any type by subject report

4. Having chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol

5. Having any significant disease (either acute or chronic) or who is taking medication with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of PerioWave®

6. Having an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis

7. Treatment 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

8. Known allergy to methylene blue

9. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report

10. Currently uses anti-coagulant therapy at therapeutic doses

11. Currently uses photosensitizing medications

12. Participated in investigational treatment in the last 30 days or expectation for using a separate investigational treatment during the time of the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Device:
• PerioWave

Procedure:
• Scaling and Root Planing

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	University of Western Ontario	London	Ontario
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Canada	North York Dental Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ondine Research Laboratories

Country where clinical trial is conducted

Canada, 

References & Publications (45)

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Johnson V, Johnson BD, Sims TJ, Whitney CW, Moncla BJ, Engel LD, Page RC. Effects of treatment on antibody titer to Porphyromonas gingivalis in gingival crevicular fluid of patients with rapidly progressive periodontitis. J Periodontol. 1993 Jun;64(6):559-65. — View Citation

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Paardekooper M, De Bruijne AW, Van Steveninck J, Van den Broek PJ. Inhibition of transport systems in yeast by photodynamic treatment with toluidine blue. Biochim Biophys Acta. 1993 Sep 19;1151(2):143-8. — View Citation

Paardekooper M, De Bruijne AW, Van Steveninck J, Van den Broek PJ. Intracellular damage in yeast cells caused by photodynamic treatment with toluidine blue. Photochem Photobiol. 1995 Jan;61(1):84-9. — View Citation

Paardekooper M, Van den Broek PJ, De Bruijne AW, Elferink JG, Dubbelman TM, Van Steveninck J. Photodynamic treatment of yeast cells with the dye toluidine blue: all-or-none loss of plasma membrane barrier properties. Biochim Biophys Acta. 1992 Jul 8;1108(1):86-90. — View Citation

Position paper: epidemiology of periodontal diseases. American Academy of Periodontology. J Periodontol. 1996 Sep;67(9):935-45. Review. — View Citation

Quirynen M, Op Heij DG, Adriansens A, Opdebeeck HM, van Steenberghe D. Periodontal health of orthodontically extruded impacted teeth. A split-mouth, long-term clinical evaluation. J Periodontol. 2000 Nov;71(11):1708-14. — View Citation

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Smetana Z, Ben-Hur E, Mendelson E, Salzberg S, Wagner P, Malik Z. Herpes simplex virus proteins are damaged following photodynamic inactivation with phthalocyanines. J Photochem Photobiol B. 1998 Jun 15;44(1):77-83. — View Citation

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Wilson M, Dobson J, Sarkar S. Sensitization of periodontopathogenic bacteria to killing by light from a low-power laser. Oral Microbiol Immunol. 1993 Jun;8(3):182-7. — View Citation

Wilson M, Mia N. Sensitisation of Candida albicans to killing by low-power laser light. J Oral Pathol Med. 1993 Sep;22(8):354-7. — View Citation

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in clinical attachment level		6, 12 weeks
Secondary	Decrease in periodontal pocket depth		6, 12 weeks
Secondary	Reduction in bleeding on probing		6, 12 weeks