Effectiveness of a novel topical powder on the treatment of traumatic oral ulcers in orthodontic patients: A randomized controlled trial

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 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.

Keywords: Duration; Pain; Traumatic oral ulcers; Treatment; Ulcer size.

Figures

Figure 1.

Diagram of patient flow throughout the trial.

Figure 2.

Record of lesion size and three questions pertaining to the pain.

Figure 3.

Clinical presentation of ulcers from wire pokes (top panel) and injuries other than wire pokes (bottom panel).

Figure 4.

Ulcer size recorded each morning (M) and night (N), along with significant (P

Figure 5.

Rates of ulcer size change based on the multilevel estimates.

Figure 6.

Percentages of patients with complete ulcer resolution, along with significant (P

Figure 7.

Pain when the ulcer is touched as recorded each morning (M) and night (N), along with significant (P