Stain Control Efficacy and Tolerability of an Oral Hygiene Regimen

Objectives: To determine whether an Experimental toothpaste, toothbrush and post-brushing mouthrinse (TTM) regimen prevented tooth stain accumulation and promoted stain removal versus a conventional marketed toothpaste and toothbrush (TT) regimen, and to study the Experimental regimen’s oral tolerability.
Methods: This program involved a stain control study (1) and an oral soft tissue (OST) tolerability study (2): both were single-centre, examiner-blind, healthy-volunteer designs. Study 1 had a 4-week stain-induction phase, followed by a 6-week stain-reduction phase (3 cells, N=423). After dental prophylaxis, subjects were randomised to an Experimental TTM regimen (1 cell) or a Reference TT regimen (2 cells). The Experimental toothpaste and mouthrinse contained the stain-control agent, sodium tripolyphosphate, at 5% and 1.2% respectively. Subjects used their allocated treatment 2x/day for 4 weeks, rinsing with fresh tea 3x/day to encourage stain development. After 4 weeks, subjects’ stain levels were assessed using the modified Lobene stain index (intensity), and tea-rinsing stopped. Subjects using the Reference regimen were then divided: one cell continued as before, the other switched to the Experimental regimen. Stain was re-assessed after 6 weeks. In study 2, the Experimental regimen or a marketed whitening TTM regimen (2 cells, N=208) were used 2x/day for 28 days. An OST examination was completed at baseline, 7 and 28 days.
Results: In study 1, stain accumulation in the Experimental TTM group was 8.3% lower (p=0.0364) and stain reduction was 28.7% greater than the Reference TT group (p<0.0001). There were 11 treatment-related adverse events (TRAEs). In study 2, there were 4 TRAEs in the Experimental TTM group, and 20 in the Reference TTM group. In both studies, mild desquamation and ulceration were the most frequent TRAEs.
Conclusions: The Experimental toothbrushing-mouthrinsing regimen prevented stain accumulation and promoted stain removal, compared to conventional toothbrushing with toothpaste alone. The Experimental regimen was well-tolerated. Studies funded by GSK Consumer Healthcare.