RESUMEN
Objective: To assess the clinical, microbiological, and patient-based effects of using a cetylpyridinium chloride (CPC) toothpaste and mouth rinse in orthodontic patients. Design: Parallel randomized controlled, triple-blinded trial (participants, examiners, outcomes' assessors). A computer-generated list was used to allocate treatments. Central allocation was used for concealment. Participants: Thirty-one placebo (10 males, 21 females; mean age 15.2 ± 2.1) and 32 test patients (15 males, 17 females; mean age 15.0 ± 1.8) with fixed orthodontic appliance were included in the study. Interventions: Patients were randomly assigned to both brush and rinse with placebo or with CPC-based products. Products were purposely prepared in white opaque bottles. After screening and professional prophylaxis, patients received a baseline examination, and started to use the assigned products. Patients were monthly assessed during a 3-month period. Main outcome measures: Plaque (PlI) and gingival (GI) indexes. Secondary outcome variables: Calculus index, tooth staining, subgingival microbiological samples, patient-based variables (questionnaire, compliance, and remaining mouth rinse), side-effects (debonded braces or mucosal injuries). Results: Sixty-three patients were randomized, 13 patients were excluded from analysis because of early dropout, leaving 50 patients for intention to treat analysis. PlI in the upper jaw diminished (0.18; SD = 0.82) after 1 month in the test group, while it increased (0.26; SD = 0.62) in the placebo group (P = 0.024). Statistically significant higher GI values were observed in the placebo group at 1 month (mean increase = 0.05; SD = 0.33 versus mean decrease = 0.03; SD = 0.38) and 3 months (mean = 0.05; SD = 0.43 versus mean = 0.02; SD = 0.34). The taste of the test product was rated higher than the placebo at 2- and 3-month visits (P < 0.05). Non-significant changes were observed in microbiological parameters, overgrowth of opportunistic species or remaining secondary outcome variables, including side-effects. Conclusion: The use of CPC-based toothpaste and mouth rinse in orthodontic patients had limited effect in reducing plaque accumulation and gingival inflammation. Effects were little and highly variable. The use of the test products was not associated with relevant adverse effects. Trial registration: Trial registration: Local internal reference: P07/133.
