Lauren A Rennick1, Phillip M Campbell2, Aparna Naidu3, Reginald W Taylor4, Peter H Buschang5. 1. a Private practice, Charlotte, NC. 2. b Associate Professor and Chairman, Orthodontic Department, Texas A&M University Baylor College of Dentistry, Dallas, Tex. 3. c Assistant Professor, Oral Pathology, Texas A&M University Baylor College of Dentistry, Dallas, Tex. 4. d Associate Professor, Orthodontic Department, Texas A&M University Baylor College of Dentistry, Dallas, Tex. 5. e Regents Professor and Director of Orthodontic Research, Orthodontic Department, Texas A&M University Baylor College of Dentistry, Dallas, Tex.
Abstract
OBJECTIVE: To determine if 2-DeNT Oral Topical Powder is an effective treatment for traumatic oral ulcers. MATERIALS AND METHODS: Of the 46 patients who were randomly allocated, 20 patients from the experimental group and 17 from theplacebo control group completed the study. The patients, operators, and evaluators were all blinded. Patients applied the powder twice a day and completed a diary twice a day for 10 days. The diary was used to monitor the size of the lesions and pain levels (using a 10-cm visual analog scale). RESULTS: By day 5, the ulcers in the experimental group had reduced in size by approximately 70%; and ulcers in the control group had reduced in size by 56%. The experimental-group ulcers were significantly (P < .05) smaller than the control-group ulcers from day 5 through day 9. Ulcers in the experimental group were completely resolved by day 8, whereas control-group ulcers were still present on day 10. Patients experienced a significant amount of stimulated pain until the night of day 2 in the experimental group and until the night of day 5 in the control group, but group differences in pain were not statistically significant. CONCLUSIONS: The 2DeNT Oral Topical powder was more effective than the placebo powder at accelerating the healing of oral traumatic ulcers.
RCT Entities:
OBJECTIVE: To determine if 2-DeNT Oral Topical Powder is an effective treatment for traumatic oral ulcers. MATERIALS AND METHODS: Of the 46 patients who were randomly allocated, 20 patients from the experimental group and 17 from the placebo control group completed the study. The patients, operators, and evaluators were all blinded. Patients applied the powder twice a day and completed a diary twice a day for 10 days. The diary was used to monitor the size of the lesions and pain levels (using a 10-cm visual analog scale). RESULTS: By day 5, the ulcers in the experimental group had reduced in size by approximately 70%; and ulcers in the control group had reduced in size by 56%. The experimental-group ulcers were significantly (P < .05) smaller than the control-group ulcers from day 5 through day 9. Ulcers in the experimental group were completely resolved by day 8, whereas control-group ulcers were still present on day 10. Patients experienced a significant amount of stimulated pain until the night of day 2 in the experimental group and until the night of day 5 in the control group, but group differences in pain were not statistically significant. CONCLUSIONS: The 2DeNT Oral Topical powder was more effective than the placebo powder at accelerating the healing of oral traumatic ulcers.