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

NCT ID: NCT00167466

Last Updated: 2010-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2010-05-31

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).

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Soladey-3 toothbrush

Intervention Type: DEVICE

subject to brush with experimental Soladey-3 brush for 4 week

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

Group Type: PLACEBO_COMPARATOR

Placebo Soladey-3 toothbrush

Intervention Type: DEVICE

subjects will brush with placebo Soladey-3 toothbrush for 4 weeks

Interventions

Soladey-3 toothbrush

subject to brush with experimental Soladey-3 brush for 4 week

Intervention Type: DEVICE

Placebo Soladey-3 toothbrush

subjects will brush with placebo Soladey-3 toothbrush for 4 weeks

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiken Corporation

INDUSTRY

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

University of Saskatchewan

Principal Investigators

Gerry Uswak

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

University of Saskatchewan College of Dentistry

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

Bio-REB 05-20

Identifier Type: -

Identifier Source: org_study_id