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

Area of Science:

• Dentistry
• Cosmetic Dentistry
• Oral Hygiene

Background:

• Extrinsic tooth staining is a common aesthetic concern.
• Existing toothpastes vary in their efficacy for stain removal and whitening.
• The development of novel dentifrice formulations is crucial for improving oral aesthetics.

Purpose of the Study:

• To evaluate the extrinsic tooth stain removal and whitening efficacy of two experimental dentifrices.
• To compare the efficacy of experimental dentifrices containing 5% sodium tripolyphosphate (STP)/1% micronized alumina (with or without abrasive silica) against a regular fluoride dentifrice (RFD).

Main Methods:

• A single-center, randomized, controlled, blind, three-arm, parallel-group study.
• Participants used assigned dentifrices twice daily for 8 weeks.
• Stain was assessed using the modified Lobene stain index (MLSI); tooth shade was evaluated using the VITA Bleachedguide 3D-Master (VITA) shade guide at baseline, 4 weeks, and 8 weeks.

Main Results:

• Both experimental dentifrices showed statistically significant reductions in MLSI and VITA shade scores from baseline at 4 and 8 weeks.
• Significant differences in stain reduction and shade improvement were observed compared to the RFD group.
• Ten treatment-related adverse events were reported in seven participants, all resolved by study end.

Conclusions:

• Dentifrices containing 5% STP/1% micronized alumina demonstrate superior extrinsic tooth stain removal and whitening efficacy compared to regular fluoride dentifrices.
• These formulations are well-tolerated and suitable for daily use, offering clinically meaningful improvements in tooth appearance.
• A low-abrasion formulation with STP and micronized alumina is beneficial for individuals at risk of tooth wear or hypersensitivity.