Placebo Controlled Trial of a Titanium Dioxide Semiconductor Toothbrush on Mild-to-moderate Gum Disease
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Soladey-3 toothbrush
Placebo Soladey-3 toothbrush
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring periodontal disease, toothbrush, titanium dioxide semiconductor, mild-to-moderate periodontal disease, adult patients 18 to 70 years of age
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
Sites / Locations
- University of Saskatchewan College of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
4 week brushing with experimental Soladey-3 toothbrush followed by 4 week washout period followed by 4 week brushing with placebo Soladey-3 toothbrush
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
Outcomes
Primary Outcome Measures
gingivitis index
plaque index
Secondary Outcome Measures
subjective comments re: functionality of of the Soladey-3 toothbrush compared to conventional toothbrush.
Full Information
NCT ID
NCT00167466
First Posted
September 9, 2005
Last Updated
October 26, 2010
Sponsor
University of Saskatchewan
Collaborators
Shiken Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00167466
Brief Title
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
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Saskatchewan
Collaborators
Shiken Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
periodontal disease, toothbrush, titanium dioxide semiconductor, mild-to-moderate periodontal disease, adult patients 18 to 70 years of age
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
4 week brushing with experimental Soladey-3 toothbrush followed by 4 week washout period followed by 4 week brushing with placebo Soladey-3 toothbrush
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Soladey-3 toothbrush
Intervention Description
subject to brush with experimental Soladey-3 brush for 4 week
Intervention Type
Device
Intervention Name(s)
Placebo Soladey-3 toothbrush
Intervention Description
subjects will brush with placebo Soladey-3 toothbrush for 4 weeks
Primary Outcome Measure Information:
Title
gingivitis index
Time Frame
4 measurements 4 weeks apart
Title
plaque index
Time Frame
4 measurements 4 weeks apart
Secondary Outcome Measure Information:
Title
subjective comments re: functionality of of the Soladey-3 toothbrush compared to conventional toothbrush.
Time Frame
End of study assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerry Uswak
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan College of Dentistry
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5E5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Placebo Controlled Trial of a Titanium Dioxide Semiconductor Toothbrush on Mild-to-moderate Gum Disease
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