Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167466
Status:
COMPLETED
Last Update Posted:
2010-10-28
First Post:
2005-09-09
Brief Title:
Placebo Controlled Trial of a Titanium Dioxide Semiconductor Toothbrush on Mild-to-moderate Gum Disease
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The effects on indices of gingivitisperiodontitis 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None