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PeriodontitisPhase 4NCT00296881

SRP in Combination With PERIOWAVE in Comparison to SRP Alone in Chronic Periodontitis

A Phase 4 study testing PERIOWAVE in people with Periodontitis, run by Ondine Research Laboratories at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. 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
80 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2006to Dec 2007
Phase
Phase 4
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
  • Subject is willing to sign a consent form
  • Adult male or female ≥ the age of 18
  • Having been diagnosed with chronic periodontitis
  • >18 fully erupted teeth
  • Has had no periodontal instrumentation in the four months prior to the initiation of study treatment
  • Subject has at least 4 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

  • Is pregnant or nursing or who plans to become pregnant in the next 4 months
  • Having significant liver disease by subject report
  • Having an active malignancy of any type by subject report
  • Having chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
  • Having any significant chronic disease (either acute or chronic) with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of PerioWave®
  • Having an active periapical abscess or periodontal abscess
Show all 13Show fewer
  • Treatment with antibiotics with in 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
  • History of acute necrotizing ulcerative gingivitis
  • Known allergy to Methylene Blue
  • Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
  • Currently uses anti-coagulant therapy at therapeutic doses
  • Currently uses photosensitizing medications
  • Participated in investigational treatment in the last 30 days or expectation for using a separate investigational treatment during the time of the study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • UCL Eastman Dental Institute

    London, WC1X 8LD

Other trials in United Kingdom

About this study

Official title: Clinical Outcomes Following Non-Surgical Treatment of Chronic Periodontitis, Using Scaling and Root Planing (SRP) in Conjunction With PerioWave, Compared to SRP Alone

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.

Read the detailed 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.

Conditions
Periodontitis
Being tested
PERIOWAVE
Keywords
Periodontitis, Photodynamic Disinfection, PERIOWAVE, Scaling and Root Planing, SRP
Medical subject headings
Periodontitis

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. Decrease in Periodontal Pocket Depth

    Measured: 6, 12, 24, 36, 48 weeks

Secondary outcomes (2)

  1. Reduction in Bleeding on Probing

    Measured: 6, 12, 24, 36, 48 weeks

  2. Increase in Clinical Attachment Level

    Measured: 6, 12, 24, 36, 48 weeks

Timeline

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

  1. First posted27 Feb 2006 (estimated)
  2. Study startApr 2006
  3. Study completionDec 2007 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00296881
Sponsor's protocol ID
ORL-0605-3
Status last verified
May 2007
First submitted
23 Feb 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 4 study testing PERIOWAVE in people with Periodontitis, run by Ondine Research Laboratories at 1 site in United Kingdom.

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 8 inclusion and 13 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: status not confirmed, 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 1 site in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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?

Decrease in Periodontal Pocket Depth (time frame: 6, 12, 24, 36, 48 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 NCT00296881, 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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