TY - JOUR
T1 - An evaluation of 10 percent and 20 percent benzocaine gels in patients with acute toothaches
T2 - Efficacy, tolerability and compliance with label dose administration directions
AU - Hersh, Elliot V.
AU - Ciancio, Sebastian G.
AU - Kuperstein, Arthur S.
AU - Stoopler, Eric T.
AU - Moore, Paul A.
AU - Boynes, Sean G.
AU - Levine, Steven C.
AU - Casamassimo, Paul
AU - Leyva, Rina
AU - Mathew, Tanya
AU - Shibly, Othman
AU - Creighton, Paul
AU - Jeffers, Gary E.
AU - Corby, Patricia M.A.
AU - Turetzky, Stanley M.
AU - Papas, Athena
AU - Wallen, Jillian
AU - Idzik-Starr, Cynthia
AU - Gordon, Sharon M.
N1 - Funding Information:
This study was supported by a grant from Pfizer Consumer Healthcare (Madison, N.J.) and Church & Dwight (Princeton, N.J.) to Drs. Hersh, Ciancio, Moore, Casamassimo, Jeffers, Corby, Papas and Gordon.
PY - 2013/5
Y1 - 2013/5
N2 - Background: The authors evaluated the efficacy and tolerability of 10 percent and 20 percent benzocaine gels compared with those of a vehicle (placebo) gel for the temporary relief of toothache pain. They also assessed the compliance with the label dose administration directions on the part of participants with toothache pain. Methods: Under double-masked conditions, 576 participants self-applied study gel to an open tooth cavity and surrounding oral tissues. Participants evaluated their pain intensity and pain relief for 120 minutes. The authors determined the amount of gel the participants applied. Results: The responders' rates (the primary efficacy parameter), defined as the percentage of participants who had an improvement in pain intensity as exhibited by a pain score reduction of at least one unit on the dental pain scale from baseline for two consecutive assessments any time between the five- and 20-minute points, were 87.3 percent, 80.7 percent and 70.4 percent, respectively, for 20 percent benzocaine gel, 10 percent benzocaine gel and vehicle gel. Both benzocaine gels were significantly (P ≤.05) better than vehicle gel; the 20 percent benzocaine gel also was significantly (P ≤.05) better than the 10 percent benzocaine gel. The mean amount of gel applied was 235.6 milligrams, with 88.2 percent of participants applying 400 mg or less. Conclusions: Both 10 percent and 20 percent benzocaine gels were more efficacious than the vehicle gel, and the 20 percent benzocaine gel was more efficacious than the 10 percent benzocaine gel. All treatments were well tolerated by participants. Practical Implications: Patients can use 10 percent and 20 percent benzocaine gels to temporarily treat toothache pain safely.
AB - Background: The authors evaluated the efficacy and tolerability of 10 percent and 20 percent benzocaine gels compared with those of a vehicle (placebo) gel for the temporary relief of toothache pain. They also assessed the compliance with the label dose administration directions on the part of participants with toothache pain. Methods: Under double-masked conditions, 576 participants self-applied study gel to an open tooth cavity and surrounding oral tissues. Participants evaluated their pain intensity and pain relief for 120 minutes. The authors determined the amount of gel the participants applied. Results: The responders' rates (the primary efficacy parameter), defined as the percentage of participants who had an improvement in pain intensity as exhibited by a pain score reduction of at least one unit on the dental pain scale from baseline for two consecutive assessments any time between the five- and 20-minute points, were 87.3 percent, 80.7 percent and 70.4 percent, respectively, for 20 percent benzocaine gel, 10 percent benzocaine gel and vehicle gel. Both benzocaine gels were significantly (P ≤.05) better than vehicle gel; the 20 percent benzocaine gel also was significantly (P ≤.05) better than the 10 percent benzocaine gel. The mean amount of gel applied was 235.6 milligrams, with 88.2 percent of participants applying 400 mg or less. Conclusions: Both 10 percent and 20 percent benzocaine gels were more efficacious than the vehicle gel, and the 20 percent benzocaine gel was more efficacious than the 10 percent benzocaine gel. All treatments were well tolerated by participants. Practical Implications: Patients can use 10 percent and 20 percent benzocaine gels to temporarily treat toothache pain safely.
KW - Benzocaine
KW - Double stopwatch
KW - Methemoglobinemia
KW - Pain
KW - Toothache
KW - Topical anesthetic
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U2 - 10.14219/jada.archive.2013.0154
DO - 10.14219/jada.archive.2013.0154
M3 - Article
C2 - 23633700
AN - SCOPUS:84878430581
SN - 0002-8177
VL - 144
SP - 517
EP - 526
JO - Journal of the American Dental Association
JF - Journal of the American Dental Association
IS - 5
ER -