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

Randomized, Double-blind, Placebo-controlled Crossover Trial of the Soladey-3 Toothbrush on Periodontal Disease Indices in Patients With Mild-to-moderate Periodontal Disease

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Device: Soladey-3 toothbrush; Device: Placebo Soladey-3 toothbrush

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).

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 5E5
      • University of Saskatchewan College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 30 to 70 yrs of age
• mild-to-moderate periodontal disease
• dentulous

Exclusion Criteria:

• any unstable medical condition
• pocket depth > 5 mm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
gingivitis index	4 measurements 4 weeks apart
plaque index	4 measurements 4 weeks apart

Secondary Outcome Measures

Outcome Measure	Time Frame
subjective comments re: functionality of of the Soladey-3 toothbrush compared to conventional toothbrush.	End of study assessment

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Shiken Corporation
• Investigators: Principal Investigator: Gerry Uswak, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): October 28, 2010
• Last Update Submitted That Met QC Criteria: October 26, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: periodontal disease; toothbrush; titanium dioxide semiconductor; mild-to-moderate periodontal disease; adult patients 18 to 70 years of age
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: Bio-REB 05-20