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Placebo Controlled Trial of a Titanium Dioxide Semiconductor Toothbrush on Mild-to-moderate Gum Disease

This study has been completed.
Sponsor:
Collaborator:
Shiken Corporation
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00167466
First received: September 9, 2005
Last updated: October 26, 2010
Last verified: October 2010

September 9, 2005
October 26, 2010
October 2005
May 2010   (final data collection date for primary outcome measure)
  • gingivitis index [ Time Frame: 4 measurements 4 weeks apart ] [ Designated as safety issue: No ]
  • plaque index [ Time Frame: 4 measurements 4 weeks apart ] [ Designated as safety issue: No ]
  • gingivitis index
  • plaque index
  • gingival crevice fluid flow
  • gingival pocket temperature
Complete list of historical versions of study NCT00167466 on ClinicalTrials.gov Archive Site
subjective comments re: functionality of of the Soladey-3 toothbrush compared to conventional toothbrush. [ Time Frame: End of study assessment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Placebo Controlled Trial of a Titanium Dioxide Semiconductor Toothbrush on Mild-to-moderate Gum Disease
Randomized, Double-blind, Placebo-controlled Crossover Trial of the Soladey-3 Toothbrush on Periodontal Disease Indices in Patients With Mild-to-moderate Periodontal Disease

The effects on indices of gingivitis/periodontitis will differ between study arms in which the titanium dioxide semiconductor toothbrush is used, compared to an otherwise identical toothbrush with an inert resin core in place of the titanium dioxide semiconductor.

Organic acid producing anaerobic bacteria are implicated in the development and progression of gingivitis and periodontal disease (Brill, 1962; Kleinberg, 1974). The disease process manifests as periodontal inflammation and tissue destruction (Oliver et al, 1969). Although relatively crude methods are used for routine clinical diagnosis and monitoring of periodontal disease (eg, probing for gingival pocket depth and bleeding), sensitive and reproducible measures of periodontal disease have been validated (Oliver et al, 1969; Löe et al, 1965; Egelberg, 1964; Golub et al, 1976; Borden et al, 1977).

By the Lewis definition, an acid is an electron pair acceptor. In the presence of light &/or electrical induction, valence electrons from a wetted titanium dioxide (TiO2) semiconductor will donate electron pairs to neutralize organic acids. Whereas a tooth surface is negatively charged, plaque has a net positive charge, and in part, ionic attraction contributes to the adherence of plaque to the tooth surface. Donating electrons to the plaque will alter polarity and diminish the ionic attraction between the plaque and the tooth surface (iontophoretic effect).

Thus, in addition to the established mechanical benefits of brushing, the flow of electron pairs for disrupting ionic bonding of plaque to the tooth surface and neutralizing bacterial organic acids, may confer an advantage over a conventional toothbrush (Hoover et al, 1992; Niwa et al, 1989; Kusunoki et al, 1986). There is some evidence that the electrons may also interact with bacterial coenzyme-A to have an antibacterial effect (Morioka et al, 1988; Onoda et al, 1996).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Periodontal Diseases
  • Device: Soladey-3 toothbrush
    subject to brush with experimental Soladey-3 brush for 4 week
  • Device: Placebo Soladey-3 toothbrush
    subjects will brush with placebo Soladey-3 toothbrush for 4 weeks
  • Experimental: A
    4 week brushing with experimental Soladey-3 toothbrush followed by 4 week washout period followed by 4 week brushing with placebo Soladey-3 toothbrush
    Intervention: Device: Soladey-3 toothbrush
  • Placebo Comparator: B
    subjects to brush with Placebo Soladey-3 toothbrush for 4 weeks followed by a 4 week washout followed by 4 week brushing with experimental Soladey-3 toothbrush
    Intervention: Device: Placebo Soladey-3 toothbrush
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 30 to 70 yrs of age
  • mild-to-moderate periodontal disease
  • dentulous

Exclusion Criteria:

  • any unstable medical condition
  • pocket depth > 5 mm
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00167466
Bio-REB 05-20
Yes
Dr. Gerry Uswak, University of Saskatchewan
University of Saskatchewan
Shiken Corporation
Principal Investigator: Gerry Uswak University of Saskatchewan
University of Saskatchewan
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP