The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.
The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations. Adverse events will be tracked through study dental examinations and subject diaries with twice daily use of the 3M Oral Rinse used in combination with toothpaste containing one of three levels (no, medium, high) of Sodium Lauryl Sulfate (SLS). Determine the subjects' acceptance of sloughing and/or other side effects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
53
Toothpaste no Sodium Lauryl Sulfate
Less than or equal to X ppm Sodium Lauryl Sulfate
More than or equal to X ppm Sodium Lauryl Sulfate
3M Health Care
Saint Paul, Minnesota, United States
Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.
Time frame: End of treatment (3 weeks)
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right)
Time frame: Mid-Treatment (10 days)
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.
Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right)
Time frame: End of Treatment (3 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rinse prevents bacterial adherence to teeth