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Background  Oral care is important for oral and systemic health, especially for elderly institutionalized individuals and compromised patients. However, conventional mechanical plaque control is often difficult for these patients because of the pain or the risk of aspiration. Although antimicrobial photodynamic therapy (aPDT), which is considered an alternative or adjunct to mechanical approaches, has potential application as a less stressful method of daily plaque control, no clinical application of this technique has been reported.    Methods  We investigated the inhibitory effect of a combination of toluidine blue O (TBO), and a red light-emitting diode (LED) on dental plaque formation in healthy volunteers. The optimal concentration of TBO was determined in preliminary  in vitro  experiments to evaluate the bactericidal effect of aPDT on  Streptococcus oralis  and to clarify its safety in fibroblast cells. To survey the mechanism of TBO-mediated aPDT, the quality and quantity of reactive oxygen species (ROS) generated during aPDT were also examined using electron spin resonance (ESR) spectroscopy. Subsequently, the inhibitory effect of aPDT on dental plaque formation was investigated in eleven subjects as a clinical pilot study. The right or left mandibular premolars were randomly assigned to the treatment (with aPDT) or control (without aPDT) groups. In total, aPDT was applied six times (twice per day) to the teeth in the test group over a period of four days. On the fourth day, the study concluded and the analyses were performed.    Results  A combination of 500 or 1000 μg/ml TBO and LED irradiation for 20 s significantly decreased the number of colony forming units of  Streptococcus oralis . The cytotoxicity of aPDT was comparable to that of standard antiseptics used in the oral cavity. Hydroxyl radicals were detected by ESR analysis, but singlet oxygen was not. A randomized controlled trial demonstrated that aPDT with 1000 μg/ml TBO and red LED irradiation significantly suppressed dental plaque formation without harming teeth or the surrounding tissues.    Conclusions  aPDT has the potential to be a promising novel technical modality for dental plaque control.    Trial registration  This trial was registered with University Hospital Medical Information Network Clinical Trials Registry (number  UMIN000012504 ).    Electronic supplementary material  The online version of this article (doi:10.1186/1472-6831-14-152) contains supplementary material, which is available to authorized users.

Antimicrobial photodynamic therapy suppresses dental plaque formation in healthy adults: a randomized controlled clinical trial