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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Randomized, Double-blind, Placebo-controlled Crossover Trial of the Soladey-3 Toothbrush on Periodontal Disease Indices in Patients With Mild-to-moderate Periodontal Disease

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Device: Soladey-3 toothbrush
* Device: Placebo Soladey-3 toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 to 70 yrs of age mild-to-moderate periodontal disease dentulous Exclusion Criteria: any unstable medical condition pocket depth > 5 mm

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* subject to brush with experimental Soladey-3 brush for 4 week<br>|
| Placebo Comparator: B<br>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<br>* subjects will brush with placebo Soladey-3 toothbrush for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gingivitis index |  | 4 measurements 4 weeks apart | 
| plaque index |  | 4 measurements 4 weeks apart | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective comments re: functionality of of the Soladey-3 toothbrush compared to conventional toothbrush. |  | End of study assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontal disease, toothbrush, titanium dioxide semiconductor, mild-to-moderate periodontal disease, adult patients 18 to 70 years of age