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Clinical study to compare extrinsic stain formation in subjects using three dentifrice formulations
N Conforti1, S Mankodi, Y P Zhang
1Dental Products Testing, Inc., Lake Worth, Florida, USA.
Compendium of Continuing Education in Dentistry. (Jamesburg, N.J. : 1995). Supplement
|March 23, 2002
Summary
A new toothpaste with potassium nitrate and stannous fluoride showed no increased extrinsic dental stain compared to standard toothpastes. This finding supports its safety for daily use in preventing tooth staining.
Area of Science:
- Dental Science
- Oral Hygiene
- Cosmetic Dentistry
Background:
- Extrinsic dental stains impact aesthetics and patient satisfaction.
- Evaluating new dentifrice formulations for potential side effects like staining is crucial.
- Existing dentifrices vary in active ingredients and their impact on stain formation.
Purpose of the Study:
- To compare extrinsic dental stain formation using a new dentifrice (5.0% potassium nitrate, 0.454% stannous fluoride) against two commercial dentifrices.
- To assess the safety of the new dentifrice formulation regarding its potential to cause extrinsic dental staining.
- To determine if the new dentifrice formulation leads to statistically significant differences in stain area or intensity over 8 weeks.
Main Methods:
- A randomized controlled study involving 121 participants stratified by baseline Lobene Stain Index scores.
- Participants used one of three assigned dentifrices (new formulation, commercial with potassium nitrate/sodium fluoride, commercial with sodium fluoride) twice daily for 8 weeks.
- Extrinsic dental stain assessments (area and intensity) were performed at baseline, 4 weeks, and 8 weeks by a single examiner.
Main Results:
- No statistically significant differences in extrinsic dental stain formation were observed among the three dentifrice groups after 4 and 8 weeks.
- The new dentifrice formulation did not result in greater extrinsic stain formation compared to the control dentifrices.
- Baseline stain levels, gender, and tobacco habits were balanced across the study groups.
Conclusions:
- The new dentifrice formulation containing 5.0% potassium nitrate and 0.454% stannous fluoride does not cause increased extrinsic dental staining.
- This formulation is comparable to commercially available dentifrices in terms of extrinsic stain development.
- The study supports the safety of the new dentifrice for managing extrinsic dental stain.