Efficacy of an anti-discoloration system (ADS) in a 0.12% chlorhexidine mouthwash: A triple blind, randomized clinical trial.

PURPOSE: To determine the efficacy of an anti-discoloration system (ADS) in a 0.12% chlorhexidine (CHX) mouthwash to reduce dental discoloration. METHODS: A triple-blind, cross-over, randomized clinical trial was carried out in 22 healthy volunteers asked to perform oral rinses, twice a day for 21 days, using 0.12% CHX mouthwashes containing or not ADS (wash-out= 21 days). Dental discolorations were compared via spectroscopy (DeltaE), and direct visual examination performed by the dentist and volunteers themselves. At 6 months, a further visual analysis on clinical images was carried out by the same volunteers and ad hoc recruited dental practitioners. RESULTS: A slight discoloration was the most frequent finding, independent of the presence of ADS, while the few severe cases of staining were associated with CHX alone. (DeltaE values comparing dental color before and after treatments were similar for CHX (8.4+/-0.1) and CHX+ADS (8.6+/-0.9) rinses. Direct visual analysis showed no staining difference between the two mouthwashes. Six months later, volunteers' self-evaluation of clinical pictures again did not detect any significant difference between treatments, while dental practitioners identified CHX+ADS as less discoloring (< 0.05). Slight dental discoloration represents the most common side-effect of 0.12% CHX mouthwash, independent of the presence of ADS. Severe cases are possible, but very rare and mainly associated with CHX alone. CLINICAL SIGNIFICANCE: There was no evidence to support the 0.12% chlorhexidine with anti-discoloration agent to reduce staining.