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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167466
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : October 28, 2010
Shiken Corporation
Information provided by:
University of Saskatchewan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Device: Soladey-3 toothbrush Device: Placebo Soladey-3 toothbrush Not Applicable

Detailed Description:

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Crossover Trial of the Soladey-3 Toothbrush on Periodontal Disease Indices in Patients With Mild-to-moderate Periodontal Disease
Study Start Date : October 2005
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease

Arm Intervention/treatment
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
Device: Soladey-3 toothbrush
subject to brush with experimental Soladey-3 brush for 4 week

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
Device: Placebo Soladey-3 toothbrush
subjects will brush with placebo Soladey-3 toothbrush for 4 weeks

Primary Outcome Measures :
  1. gingivitis index [ Time Frame: 4 measurements 4 weeks apart ]
  2. plaque index [ Time Frame: 4 measurements 4 weeks apart ]

Secondary Outcome Measures :
  1. subjective comments re: functionality of of the Soladey-3 toothbrush compared to conventional toothbrush. [ Time Frame: End of study assessment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • any unstable medical condition
  • pocket depth > 5 mm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00167466

Canada, Saskatchewan
University of Saskatchewan College of Dentistry
Saskatoon, Saskatchewan, Canada, S7N 5E5
Sponsors and Collaborators
University of Saskatchewan
Shiken Corporation
Principal Investigator: Gerry Uswak University of Saskatchewan

Responsible Party: Dr. Gerry Uswak, University of Saskatchewan Identifier: NCT00167466     History of Changes
Other Study ID Numbers: Bio-REB 05-20
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: October 2010

Keywords provided by University of Saskatchewan:
periodontal disease
titanium dioxide semiconductor
mild-to-moderate periodontal disease
adult patients 18 to 70 years of age

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Titanium dioxide
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents
Photosensitizing Agents