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PeriodontitisPhase 3NCT00336661

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

A Phase 3 study testing PerioWave in people with Periodontitis, run by Ondine Research Laboratories at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 enroll a total of up to 105 subjects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Periodontitis
What is being tested?
PerioWave
Type of treatment
Medical device
How many people
105 participants
Where
2 sitesChina
Study dates
Jan 2006to Dec 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Shanghai Second Medical University

    Shanghai

  • Wenzhou Hospital Department of Dentistry

    Wenzhou

Other trials in China

About this 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

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.

Read the 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.

Conditions
Periodontitis
Being tested
PerioWave
Keywords
Periodontitis, Chronic Periodontitis, Gingivitis, PERIOWAVE, Photodynamic Disinfection
Medical subject headings
Periodontitis, Chronic Periodontitis, Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PerioWaveDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in Clinical Attachment Level

    Measured: 12-weeks

Secondary outcomes (2)

  1. Improvement in Periodontal Pocket Depth

    Measured: 12-weeks

  2. Improvement in Bleeding on Probing

    Measured: 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2006 (estimated)
  2. Study startJan 2006
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00336661
Sponsor's protocol ID
ORL-0605-2
Status last verified
May 2007
First submitted
12 Jun 2006
Last updated
21 May 2007
Results posted
No

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. doi: 10.1902/jop.1999.70.1.13.

    PubMed 10052767

  • Brown LJ, Johns BA, Wall TP. The economics of periodontal diseases. Periodontol 2000. 2002;29:223-34. doi: 10.1034/j.1600-0757.2002.290111.x. No abstract available.

    PubMed 12102710

  • 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. doi: 10.1902/jop.1999.70.1.30.

    PubMed 10052768

  • Oral health in America: a report of the Surgeon General. J Calif Dent Assoc. 2000 Sep;28(9):685-95.

    PubMed 11324049

  • Socransky SS, Haffajee AD. Evidence of bacterial etiology: a historical perspective. Periodontol 2000. 1994 Jun;5:7-25. doi: 10.1111/j.1600-0757.1994.tb00016.x. No abstract available.

    PubMed 9673160

  • Haffajee AD, Socransky SS. Microbial etiological agents of destructive periodontal diseases. Periodontol 2000. 1994 Jun;5:78-111. doi: 10.1111/j.1600-0757.1994.tb00020.x. No abstract available.

    PubMed 9673164

  • Consensus report. Periodontal diseases: epidemiology and diagnosis. Ann Periodontol. 1996 Nov;1(1):216-22. doi: 10.1902/annals.1996.1.1.216. No abstract available.

    PubMed 9118258

  • Zambon JJ. Periodontal diseases: microbial factors. Ann Periodontol. 1996 Nov;1(1):879-925. doi: 10.1902/annals.1996.1.1.879. No abstract available.

    PubMed 9118283

  • 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. doi: 10.1177/00220345970760040801.

    PubMed 9126183

  • 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. doi: 10.1902/jop.2000.71.11.1708.

    PubMed 11128918

  • 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. doi: 10.1902/jop.2001.72.3.374.

    PubMed 11327066

  • Goodson JM. Antimicrobial strategies for treatment of periodontal diseases. Periodontol 2000. 1994 Jun;5:142-68. doi: 10.1111/j.1600-0757.1994.tb00022.x. No abstract available.

    PubMed 9673166

  • 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. doi: 10.1902/jop.1993.64.6.559.

    PubMed 8393109

  • 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. doi: 10.1034/j.1600-051x.2002.291102.x.

    PubMed 12472990

  • Lindhe J, Nyman S. Long-term maintenance of patients treated for advanced periodontal disease. J Clin Periodontol. 1984 Sep;11(8):504-14. doi: 10.1111/j.1600-051x.1984.tb00902.x.

    PubMed 6384275

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PerioWave in people with Periodontitis, run by Ondine Research Laboratories at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Clinical Attachment Level (time frame: 12-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00336661, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2007.

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