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PerioWave Re-Treatment Protocol Compared to Scaling and Root Planing (SRP) and a Single Treatment With PerioWave
This study has been completed.
Sponsors and Collaborators: Ondine Research Laboratories
Loma Linda University
Information provided by: Ondine Research Laboratories
ClinicalTrials.gov Identifier: NCT00336661
  Purpose

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 enroll a total of up to 105 subjects.


Condition Intervention Phase
Periodontitis
 Device: PerioWave
 Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Blinded Study of Two Treatments of Photoactivated Disinfection With SRP Against One Treatment of Photoactivated Disinfection With SRP Against SRP Alone in the Treatment of Chronic Periodontitis

Further study details as provided by Ondine Research Laboratories:

Primary Outcome Measures:
  • Improvement in Clinical Attachment Level [ Time Frame: 12-weeks ]

Secondary Outcome Measures:
  • Improvement in Periodontal Pocket Depth [ Time Frame: 12-weeks ]
  • Improvement in Bleeding on Probing [ Time Frame: 12-weeks ]

Enrollment: 105
Study Start Date: January 2006
Study Completion Date: December 2006
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 chronic periodontitis when compared with subjects with SRP alone. This study is meant to be pivotal in nature in the evaluation of photodynamic disinfection.

Primary Endpoint

The primary outcome of interest in this study is improvement in or stabilization of clinical attachment level. The clinical attachment level is the distance in mm from the cemento-enamel junction to the base of the sulcus or periodontal pocket as measured with a periodontal probe. In order to prevent study bias all endpoint measurements will be performed by a single examiner throughout the course of the study. A clinically significant difference will be considered as:

1) A measurement difference of 0.4 mm between treatment groups

Secondary Endpoints

The secondary objectives are to assess the effects of photodynamic disinfection on clinical symptoms including reductions in probing depth and decreases in bleeding on probing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. The subject is pregnant or nursing or who plans to become pregnant in the next 4 months
  2. The subject has significant liver disease by subject report
  3. The subject has an active malignancy of any type by subject report
  4. The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
  5. 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®
  6. The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis
  7. 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
  8. The subject has a known allergy to Methylene Blue
  9. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
  10. The subject currently uses anti-coagulant therapy at therapeutic doses
  11. The subject is currently using any photosensitizing medications
  12. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336661

Locations
China
Shanghai Second Medical University
Shanghai, China
Wenzhou Hospital Department of Dentistry
Wenzhou, China
Sponsors and Collaborators
Ondine Research Laboratories
Loma Linda University
Investigators
Principal Investigator: Rong Shu Shanghai Second Medical University
Principal Investigator: Hu Zhong Wenzhou Hospital Department of Dentistry
  More Information

Publications:
Albandar JM, Brunelle JA, Kingman A. Destructive periodontal disease in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):13-29. Erratum in: J Periodontol 1999 Mar;70(3):351.
Brown LJ, Johns BA, Wall TP. The economics of periodontal diseases. Periodontol 2000. 2002;29:223-34. Review. No abstract available.
Albandar JM, Kingman A. Gingival recession, gingival bleeding, and dental calculus in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):30-43.
[No authors listed] Oral health in America: a report of the Surgeon General. J Calif Dent Assoc. 2000 Sep;28(9):685-95.
Socransky SS, Haffajee AD. Evidence of bacterial etiology: a historical perspective. Periodontol 2000. 1994 Jun;5:7-25. Review. No abstract available.
Haffajee AD, Socransky SS. Microbial etiological agents of destructive periodontal diseases. Periodontol 2000. 1994 Jun;5:78-111. Review. No abstract available.
[No authors listed] Consensus report. Periodontal diseases: epidemiology and diagnosis. Ann Periodontol. 1996 Nov;1(1):216-22. Review. No abstract available.
Zambon JJ. Periodontal diseases: microbial factors. Ann Periodontol. 1996 Nov;1(1):879-925. Review. No abstract available.
Hujoel PP, Powell LV, Kiyak HA. The effects of simple interventions on tooth mortality: findings in one trial and implications for future studies. J Dent Res. 1997 Apr;76(4):867-74.
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.
De Soete M, Mongardini C, Peuwels M, Haffajee A, Socransky S, van Steenberghe D, Quirynen M. One-stage full-mouth disinfection. Long-term microbiological results analyzed by checkerboard DNA-DNA hybridization. J Periodontol. 2001 Mar;72(3):374-82.
Goodson JM. Antimicrobial strategies for treatment of periodontal diseases. Periodontol 2000. 1994 Jun;5:142-68. Review. No abstract available.
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.
Hung HC, Douglass CW. Meta-analysis of the effect of scaling and root planing, surgical treatment and antibiotic therapies on periodontal probing depth and attachment loss. J Clin Periodontol. 2002 Nov;29(11):975-86.
Lindhe J, Nyman S. Long-term maintenance of patients treated for advanced periodontal disease. J Clin Periodontol. 1984 Sep;11(8):504-14.
Antczak-Bouckoms A, Joshipura K, Burdick E, Tulloch JF. Meta-analysis of surgical versus non-surgical methods of treatment for periodontal disease. J Clin Periodontol. 1993 Apr;20(4):259-68.
Kalkwarf KL, Kaldahl WB, Patil KD. Patient preference regarding 4 types of periodontal therapy following 3 years of maintenance follow-up. J Clin Periodontol. 1992 Nov;19(10):788-93.
McFall WT Jr. Tooth loss in 100 treated patients with periodontal disease. A long-term study. J Periodontol. 1982 Sep;53(9):539-49.
Renvert S, Wikstrom M, Dahlen G, Slots J, Egelberg J. Effect of root debridement on the elimination of Actinobacillus actinomycetemcomitans and Bacteroides gingivalis from periodontal pockets. J Clin Periodontol. 1990 Jul;17(6):345-50.
Sbordone L, Ramaglia L, Gulletta E, Iacono V. Recolonization of the subgingival microflora after scaling and root planing in human periodontitis. J Periodontol. 1990 Sep;61(9):579-84.
Haffajee AD, Cugini MA, Dibart S, Smith C, Kent RL Jr, Socransky SS. Clinical and microbiological features of subjects with adult periodontitis who responded poorly to scaling and root planing. J Clin Periodontol. 1997 Oct;24(10):767-76.
Niederman R, Abdelshehid G, Goodson JM. Periodontal therapy using local delivery of antimicrobial agents. Dent Clin North Am. 2002 Oct;46(4):665-77, viii.
Herrera D, Sanz M, Jepsen S, Needleman I, Roldan S. A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients. J Clin Periodontol. 2002;29 Suppl 3:136-59; discussion 160-2. Review.
Chung WO, Gabany J, Persson GR, Roberts MC. Distribution of erm(F) and tet(Q) genes in 4 oral bacterial species and genotypic variation between resistant and susceptible isolates. J Clin Periodontol. 2002 Feb;29(2):152-8.
Wilson M, Dobson J, Harvey W. Sensitization of oral bacteria to killing by low-power laser radiation. Curr Microbiol. 1992 Aug;25(2):77-81.
Malik Z, Hanania J, Nitzan Y. Bactericidal effects of photoactivated porphyrins--an alternative approach to antimicrobial drugs. J Photochem Photobiol B. 1990 May;5(3-4):281-93. Review.
Martinetto P, Gariglio M, Lombard GF, Fiscella B, Boggio F. Bactericidal effects induced by laser irradiation and haematoporphyrin against gram-positive and gram-negative microorganisms. Drugs Exp Clin Res. 1986;12(4):335-42.
Dobson J, Wilson M. Sensitization of oral bacteria in biofilms to killing by light from a low-power laser. Arch Oral Biol. 1992 Nov;37(11):883-7.
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.
Frentzen M, Koort HJ. Lasers in dentistry: new possibilities with advancing laser technology? Int Dent J. 1990 Dec;40(6):323-32. Review.
Sarkar S, Wilson M. Lethal photosensitization of bacteria in subgingival plaque from patients with chronic periodontitis. J Periodontal Res. 1993 May;28(3):204-10.
Bhatti M, MacRobert A, Meghji S, Henderson B, Wilson M. A study of the uptake of toluidine blue O by Porphyromonas gingivalis and the mechanism of lethal photosensitization. Photochem Photobiol. 1998 Sep;68(3):370-6.
Dougherty TJ, Grindey GB, Fiel R, Weishaupt KR, Boyle DG. Photoradiation therapy. II. Cure of animal tumors with hematoporphyrin and light. J Natl Cancer Inst. 1975 Jul;55(1):115-21.
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.
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.
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.
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.
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.
[No authors listed] Position paper: epidemiology of periodontal diseases. American Academy of Periodontology. J Periodontol. 1996 Sep;67(9):935-45. Review.
Birch JF, Mandley DJ, Williams SL, Worrall DR, Trotter PJ, Wilkinson F, Bell PR. Methylene blue based protein solder for vascular anastomoses: an in vitro burst pressure study. Lasers Surg Med. 2000;26(3):323-9.
Luksiene Z. Photodynamic therapy: mechanism of action and ways to improve the efficiency of treatment. Medicina (Kaunas). 2003;39(12):1137-50. Review.
O'Neill J, Wilson M, Wainwright M. Comparative antistreptococcal activity of photobactericidal agents. J Chemother. 2003 Aug;15(4):329-34.
Wainwright M. Photodynamic antimicrobial chemotherapy (PACT). J Antimicrob Chemother. 1998 Jul;42(1):13-28. Review.
Bertoloni G, Zambotto F, Conventi L, Reddi E, Jori G. Role of specific cellular targets in the hematoporphyrin-sensitized photoinactivation of microbial cells. Photochem Photobiol. 1987 Nov;46(5):695-8. No abstract available.
Bhatti M, Nair SP, Macrobert AJ, Henderson B, Shepherd P, Cridland J, Wilson M. Identification of photolabile outer membrane proteins of Porphyromonas gingivalis. Curr Microbiol. 2001 Aug;43(2):96-9.

Study ID Numbers: ORL-0605-2
Study First Received: June 12, 2006
Last Updated: May 17, 2007
ClinicalTrials.gov Identifier: NCT00336661  
Health Authority: China: Ethics Committee

Keywords provided by Ondine Research Laboratories:
Periodontitis
Chronic Periodontitis
Gingivitis
PERIOWAVE
Photodynamic Disinfection

Study placed in the following topic categories:
Mouth Diseases
Periodontal Diseases
Gingivitis
Periodontitis
Stomatognathic Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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