Evaluation of the efficacy of a commercially available regimen vs brushing alone on established plaque and gingivitis on adolescents: Study protocol for a randomized, controlled, blind clinical trial

BACKGROUND: Dental biofilm accumulation and poor personal oral hygiene are known major risk factors for gingivitis and halitosis. However, it is not clear how studies compare the effectiveness of hygiene regimens, associated with outcomes centered on patients. METHODS: A randomized, blind, controlled clinical trial involving 58 participants aged from 12 to 17 years, who search the Department of Pediatric Dentistry of Universidade Metropolitana de Santos, will be conducted. Immediately, the volunteers will be inserted into Group 1 (commercially available hygiene regimen) or Group 2 (tooth brushing alone). In Group 1, participants will receive Colgate Total 12 toothpastes, Plax mouthwashes and Colgate Ultrasoft toothbrushes, while Group 2 will use Colgate Cavity Protection toothpastes and Colgate Ultrasoft toothbrushes. The interventions will be conducted in the periods of 1, 3, and 6 months after the baseline, when the evaluations will also be performed. Biofilm and halitosis indexes will be evaluated. Data regarding discomfort, satisfaction and the socioeconomic/individual characteristics will also be computed. DISCUSSION: Although toothbrushing has shown positive effects in decreasing biofilm and in gingival health, there is no comparison in the literature of different brushing regimens with halitosis measurement in adolescents. In addition, the effectiveness of these protocols would be confirmed from the acceptability of the volunteers.