A Randomized Clinical Study Investigating the Stain Removal Efficacy of Two Experimental Dentifrices.

Abstract

Objective: This study aims to evaluate extrinsic tooth stain removal and whitening efficacy of two experimental dentifrices containing (i) 5% sodium tripolyphosphate (STP)/1% micronized alumina or (ii) 5% STP/1% micronized alumina with abrasive silica (ED2) compared to a regular fluoride dentifrice (RFD) following 8 weeks of use.

Materials and methods: This was a single-center, randomized, controlled, blind, three-arm, stratified, parallel-group study. Eligible participants underwent clinical assessment of stain on the facial/lingual surfaces of maxillary and mandibular teeth using the modified Lobene stain index (MLSI), and shade of the facial surfaces of the central and lateral maxillary incisors using the VITA Bleachedguide 3D-Master (VITA) shade guide. Participants brushed twice daily with their assigned dentifrice and returned to the clinic for clinical assessments at weeks 4 and 8.

Results: A total of 272 participants completed the study (281 screened, 279 randomized). Both experimental dentifrices demonstrated statistically significant reduction from baseline and significant differences compared to RFD for MLSI and VITA shade scores at 4 and 8 weeks. 10 treatment-related treatment-emergent adverse events were reported in seven participants. All were resolved at the end of the study.

Conclusions: This study demonstrated that dentifrices containing 5% STP/1% micronized alumina provide enhanced stain removal and shade improvements compared to a regular dentifrice. Study treatments were generally well tolerated.

Clinical significance: A low-abrasion daily-use fluoride dentifrice containing 1% micronized alumina and 5% STP, suitable for people at risk of erosive toothwear and/or dentin hypersensitivity, can provide clinically meaningful superior reductions in tooth stain, which translates into a visibly noticeable improvement in tooth shade.