Letícia Maíra Wambier1, Juliana Larocca de Geus2, Thaynara Faelly Boing3, João Armando Brancher1, Ana Cláudia Chibinski4, Denise Stadler Wambier4, Paulo Vitor Farago5, Alessandro D Loguercio4, Alessandra Reis6. 1. Professor, Departament of Dentistry, at the Positivo University Curitiba, Paraná, Brazil. 2. Professor, Department of Dentistry, Faculty Paulo Picanço, Fortaleza, Ceará, and Guairacá Faculty, Guarapuava, Paraná, Brazil. 3. Professor, Department of Dentistry, Guairacá Faculty, Guarapuava, Paraná, Brazil. 4. Adjunct professor, Department of Dentistry, at the State University of Ponta Grossa, Paraná, Brazil. 5. Professor, Department of Pharmaceutical Sciences, State University of Ponta Grossa, Paraná, Brazil. 6. Adjunct professor, Department of Dentistry, at the State University of Ponta Grossa, Paraná, Brazil;, Email: reis_ale@hotmail.com.
Abstract
PURPOSE:Discomfort during rubber dam clamp often occurs in pediatric dentistry. The purpose of this randomized, triple-blind, clinical trial was to evaluate the effect of pain reduction using a new topical liposomal thermo-sensitive gel (TLTG) or a placebo gel during rubber dam clamp isolation for sealants in children. METHODS:Eighty-one children (eight to 12 years old) had LTSG or the placebo gel with random assignment placed around the gingival tissue of their permanent mandibular first molars. A clamp was placed after two minutes on the teeth, and intensity of pain was registered using a Wong-Baker FACES scale and an 11-point numerical scale. The data were evaluated using McNemar's test and Wilcoxon signed rank test. RESULTS: The odds ratio for pain (OR equals 0.7; 95 percent confidence interval equals 0.3 to 1.8) was not statistically significant (P=0.52). However, there was a small difference in the pain intensity between liposomal and placebo groups for both scales (P<0.05). CONCLUSION: The liposomal thermo-sensitive anesthetic gel may reduce, to a small extent, the pain intensity in children submitted to rubber dam isolation before resin sealant placement.
RCT Entities:
PURPOSE: Discomfort during rubber dam clamp often occurs in pediatric dentistry. The purpose of this randomized, triple-blind, clinical trial was to evaluate the effect of pain reduction using a new topical liposomal thermo-sensitive gel (TLTG) or a placebo gel during rubber dam clamp isolation for sealants in children. METHODS: Eighty-one children (eight to 12 years old) had LTSG or the placebo gel with random assignment placed around the gingival tissue of their permanent mandibular first molars. A clamp was placed after two minutes on the teeth, and intensity of pain was registered using a Wong-Baker FACES scale and an 11-point numerical scale. The data were evaluated using McNemar's test and Wilcoxon signed rank test. RESULTS: The odds ratio for pain (OR equals 0.7; 95 percent confidence interval equals 0.3 to 1.8) was not statistically significant (P=0.52). However, there was a small difference in the pain intensity between liposomal and placebo groups for both scales (P<0.05). CONCLUSION: The liposomal thermo-sensitive anesthetic gel may reduce, to a small extent, the pain intensity in children submitted to rubber dam isolation before resin sealant placement.