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Efficacy of a prototype brush head for a powered toothbrush. A multicentre study.
G I McCracken1, I L Chapple, M Milward
1Restorative Dentistry, Dental School, University of Newcastle upon Tyne, UK.
Journal of Clinical Periodontology
|November 26, 2002
Summary
A multicenter trial design effectively tested powered toothbrushes (PTBs). The Philips Jordan Sensiflex 2000 prototype brush head (N2.3) showed comparable plaque removal to the Braun Oral-B D15 PTB.
Area of Science:
- Dental hygiene research
- Clinical trial methodology
- Oral health product evaluation
Background:
- Evaluating powered toothbrushes (PTBs) requires robust clinical trial designs.
- Multicenter trials are crucial for assessing product efficacy across diverse populations and settings.
- Understanding variations in PTB performance is essential for product development.
Purpose of the Study:
- To assess the suitability of a multicenter clinical trial design for evaluating PTBs.
- To compare the plaque removal efficacy of a prototype brush head (N2.3) for the Philips Jordan Sensiflex 2000 PTB against the Braun Oral-B D15 PTB.
Main Methods:
- A 2-week, 3-center, single-blind trial involving 137 volunteers (ages 18-25).
- Participants used assigned PTBs after a 48-hour oral hygiene abstinence period.
- Plaque levels were measured using a modified Quigley & Hein plaque index (PI) at full mouth, interproximal, and smooth surfaces.
Main Results:
- Analysis of variance revealed significant differences between brushing groups (P < 0.001), centers (P < 0.001), and a center-by-group interaction (P < 0.001).
- The prototype N2.3 brush head demonstrated greater plaque removal at one center (1.95 PI reduction vs. 1.13 for D15), but no difference was observed at the other two.
- The precise reasons for the observed center-specific differences in efficacy could not be determined.
Conclusions:
- A multicenter study design is applicable for PTB evaluation, with a minimum of three centers recommended to identify inter-center variations.
- The prototype N2.3 brush head for the Philips Jordan Sensiflex 2000 PTB exhibits comparable plaque removal efficacy to the Braun Oral-B D15 PTB across full mouth, interproximal, and smooth surfaces.