Studies were conducted to back claims that My Magic Mud “polishes” and “whitens” teeth, which is a matter cleaning efficacy and the extrinsic stain removal processes.
Two studies were conducted: “Stained Pellicle Removal” and “Enamel Polishing Profiles” which are highly technical and facilitated by a leading laboratory in dental product testing.
Stained Pellicle Removal:
Laboratory results demonstrate that My Magic Mud oral care products are effective at removing stains from teeth.
Both of the My Magic Mud products were significantly more effective in removing stained pellicle than the reference material. The reference material is a control to compare separate the stain removal happening from a standard toothbrush, and the effectiveness of using My Magic Mud products.
This study was run in compliance with the FDA GLP as closely as possible. This study has been conducted and reviewed according to the FDA Monograph on Anticaries Drug Products for Over the Counter Human Use and the FDA Good Laboratory Practices to the best of our knowledge.
Previous studies (J. Dent. Res., 61:1236, 1982) have indicated that the results of the stained pellicle removal test with dentifrice slurries may be considered to predict clinical findings with a reasonable degree of confidence.
Scoring and Set-Up:
The amount of in vitro stain was graded photometrically (Minolta 2600d, colorimeter) using only the L value of the LAB scale. The area of the specimens scored was a 1/4 inch diameter circle in the center of the enamel sample. Specimens with scores between 30-38 (30 being more darkly stained) were used. On the basis of these scores, the specimens were divided into groups of 16 specimens each, with each group having the same average baseline score.
Prior to running the test, eight specimens that had been prepared with the specimens used in the study were brushed to give us confidence the stain would respond as we expect. These specimens had a delta L of at least 15.0 thus the specimens were deemed acceptable.
The specimens were then mounted on a mechanical V-8 cross-brushing machine equipped with soft nylon-filament (Oral-B 40 Indicator) toothbrushes. Toothbrushes were conditioned by running brushing machine for 1,000 strokes in deionized water. Tension on the enamel surface was adjusted to 150g. The dentifrices were used as slurries prepared by mixing 25g of dentifrice with 40ml of deionized water. The ADA reference material was prepared by mixing 10g of material and 50ml of a 0.5% CMC solution. The specimens were brushed for 800 double strokes. To minimize mechanical variables, one specimen per group was brushed on each of the eight brushing heads. Fresh slurries were used for each specimen brushed. Following brushing, specimens were rinsed, blotted dry, and scored again for stain as previously described.
Enamel Polishing Profile Summary:
Summary compares usage of our toothpowder and toothpastes from 500 to 5,000 strokes. The results of the study are summarized in the attached tables as the mean polish increment at each period for each test product.
The purpose of this study was to determine polish profile of dentifrices on bovine enamel specimens.
The amount of polish was graded by a spectrophotometer. The specimens were scored for surface gloss using a Konica Minolta CM-2600d Spectrophotometer. Two readings per specimen were taken and averaged to get an average specimens score.
Following the baseline (etched) scoring, the specimens was placed on a cross-brushing machine. The brush tension was adjusted to 150 grams, and the specimens were brushed for 500 strokes with the appropriate dentifrice slurry (25 grams of dentifrice + 40 grams of deionized water) and a medium brush (Oral B-40). The specimens were then removed from the brushing machine, rinsed and scored once again for polish. The specimens were then placed back on the brushing machine (rotating V8 position), the tension readjusted and brushed for another 500 strokes (1000 total). They were then scored and rebrushed again for another 1000, 1000, 1000, 1000 strokes. This provided polishing data at 500, 1000, 2000, 3000, 4000 and 5000 strokes. The specimens were then dulled again by etching and the entire procedures were repeated for each test product.
The difference between the baseline score and the post-brushing score was calculated for each specimen and represented the polish increment. The mean and standard error of the polish increments were calculated for each group.
This study has been conducted and reviewed according to the FDA Monograph on Anticaries Drug Products for Over the Counter Human Use and the FDA Good Laboratory Practices to the best of our knowledge.
No living animals were harmed, killed, or evaluated for these studies.