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

This study has been completed.
Sponsor:
Collaborator:
Shiken Corporation
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00167466
First received: September 9, 2005
Last updated: October 26, 2010
Last verified: October 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167466

Locations
Canada, Saskatchewan
University of Saskatchewan College of Dentistry
Saskatoon, Saskatchewan, Canada, S7N 5E5
Sponsors and Collaborators
University of Saskatchewan
Shiken Corporation
Investigators
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 July 29, 2014