Clinical trial NCT00167466: Placebo Controlled Trial of a Titanium Dioxide Semiconductor Toothbrush on Mild-to-moderate Gum Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: periodontal disease
toothbrush
titanium dioxide semiconductor
mild-to-moderate periodontal disease
adult patients 18 to 70 years of age
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Shiken Corporation
First posted: 2005-09-14
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* any unstable medical condition
* pocket depth \> 5 mm

Primary outcomes:
measure: gingivitis index
timeFrame: 4 measurements 4 weeks apart
measure: plaque index
timeFrame: 4 measurements 4 weeks apart
Secondary outcomes:
measure: subjective comments re: functionality of of the Soladey-3 toothbrush compared to conventional toothbrush.
timeFrame: End of study assessment
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan College of Dentistry
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Gerry Uswak
role: PRINCIPAL_INVESTIGATOR
References: