Placebo Controlled Trial of a Titanium Dioxide Semiconductor Toothbrush on Mild-to-moderate Gum Disease
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Purpose
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 | Intervention |
|---|---|
|
Periodontal Diseases |
Device: Soladey-3 toothbrush Device: Placebo Soladey-3 toothbrush |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- gingivitis index [ Time Frame: 4 measurements 4 weeks apart ] [ Designated as safety issue: No ]
- plaque index [ Time Frame: 4 measurements 4 weeks apart ] [ Designated as safety issue: No ]
- subjective comments re: functionality of of the Soladey-3 toothbrush compared to conventional toothbrush. [ Time Frame: End of study assessment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2005 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Canada, Saskatchewan | |
| University of Saskatchewan College of Dentistry | |
| Saskatoon, Saskatchewan, Canada, S7N 5E5 | |
| Principal Investigator: | Gerry Uswak | University of Saskatchewan |
More Information
No publications provided
| Responsible Party: | Dr. Gerry Uswak, University of Saskatchewan |
| ClinicalTrials.gov Identifier: | NCT00167466 History of Changes |
| Other Study ID Numbers: | Bio-REB 05-20 |
| Study First Received: | September 9, 2005 |
| Last Updated: | October 26, 2010 |
| Health Authority: | Canada: Health Canada United States: Food and Drug Administration |
Keywords provided by University of Saskatchewan:
|
periodontal disease toothbrush titanium dioxide semiconductor mild-to-moderate periodontal disease adult patients 18 to 70 years of age |
Additional relevant MeSH terms:
|
Periodontal Diseases Mouth Diseases Stomatognathic Diseases Titanium dioxide Sunscreening Agents Radiation-Protective Agents Protective Agents |
Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses Photosensitizing Agents Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 18, 2013