CLINICAL TRIAL: EFFICACY AND SAFETY OF A NOVEL PROTOTYPE POWER TOOTHBRUSH EVALUA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to evaluate the efficacy and safety of the novel prototype power toothbrush incorporating a combination of sonic and ultrasonic physical processes in a population with moderate gingivitis. Comparison of the prototype sonic/ultrasonic toothbrush will be made to a manual toothbrush (Oral B?P35). This study will include approximately 83 participants randomized to two treatment arms with the examiner blinded to the treatment. The study will include 5 study visits for each participant in which all of the following clinical parameters will be evaluated: ? Plaque and Stain Silness and L¿e Plaque and Stain Index ? L¿e and Silness Gingival Index ? Full mouth periodontal probing depths ? Clinical attachment levels (CAL) ? Bleeding on Probing (BOP) ? Level of cytokines in the gingival crevicular fluid ? Microbial analysis of supragingival and subgingival plaque ? Adverse Events recorded on Case Report Forms