Clinical Trial Comparing Strip and Paint-on Oxalates for Dentinal Hypersensitivity
Objectives: Objective: A randomized positively-controlled trial was conducted to evaluate the durable effects of a single treatment with 1.5% oxalate strips on dentinal hypersensitivity. Methods: Method: 131 adult volunteers were screened to identify a general population with air-related cervical dentinal hypersensitivity. 60 eligible subjects were randomized to one of two oxalate groups, balancing for baseline air sensitivity and age. Oxalate treatment consisted of either 1) 1.5% oxalate gel strips (Crest® Sensi-Stop™ Strips, Procter & Gamble Co.), or 2) 3% oxalate acid potassium salt solution (Super Seal® Dental Desensitizing Liner, Phoenix Dental). All oxalate test products were professionally-applied at test sites following manufacturer’s instructions. Subsequent oral hygiene was standardized with a blinded anticavity paste and manual brush. For efficacy, dentinal hypersensitivity was assessed before/after treatment and at 30-days using a 1-sec cool air stimulus. Responses were measured by a treatment-blinded clinician using a standard 4-point scale (Schiff), and by subjects via a tablet-based pain-ranking scale (VAS). Safety was assessed by clinical examination. Results: Results: The study population was diverse with respect to gender, ethnicity and age, the latter of which ranged from 26-67 years. Overall mean (SD) sensitivity was 1.3 (0.4) for Schiff and 61.1 (17.7) for VAS. The single treatment with oxalate (strip or paint-on) yielded significant (p<0.0001) improvements in both immediate and durable sensitivity for both the clinical and subjective endpoints. The 1-month post-treatment responses were evident across measures. Adjusted Schiff means were 0.31 and 0.31 for the strip and paint-on oxalates, respectively, compared to adjusted VAS means of 23.9 and 27.4. Groups did not differ significantly (p>0.48) on clinical or subjective response after 1-month. Both treatments were well-tolerated. Conclusions: Conclusion: In randomized clinical trial, a single application of oxalate via strip or paint-on yielded 75-76% reductions in clinical sensitivity and 54-61% reductions in perceptual sensitivity one-month after treatment.(Funded by Procter and Gamble)
AADR/CADR Annual Meeting
2016 AADR/CADR Annual Meeting (Los Angeles, California) Los Angeles, California
2016 0885 Pharmacology/Therapeutics/Toxicology
Papas, Athena
( Tufts University
, Boston
, Massachusetts
, United States
)
Singh, Mabi
( Tufts University
, Boston
, Massachusetts
, United States
)
Magnuson, Britta
( Tufts University
, Boston
, Massachusetts
, United States
)
Corrado, Pamela
( Tufts University
, Boston
, Massachusetts
, United States
)
Tzavaras, Elizabeth
( Tufts University
, Boston
, Massachusetts
, United States
)
Cimmino, Joseph
( Tufts University
, Boston
, Massachusetts
, United States
)
Miner, Melanie
( Procter and Gamble
, Mason
, Ohio
, United States
)
Underwood, Jill
( Procter and Gamble
, Mason
, Ohio
, United States
)
Gerlach, Robert
( Procter & Gamble Company
, Mason
, Ohio
, United States
)
Proctor & Gamble Co.
M. Miner, J. Underwood, R.W. Gerlach work at Proctor & Gamble Co.
Dr Papas received a grant to do a subject/examiner blind study from Proctor & Gamble Co.