Topical Gel Application and Low Level Laser Therapy on Related Soft Tissue Traumatic Aphthous Ulcers: A Randomized Clinical Trial

Objective: To evaluate the effect of low level laser and Fitostimuline gel® application on pain and healing of orthodontic related traumatic aphthous. Materials and methods: In this double blind and randomized clinical trial, 60 subjects reported traumatic aphthous lesions and the same day they appear immediately they were placed in :G1: (control group) at 13 patients in which only the traumatic factor of the lesion was removed.G2: (Fitostimuline®) 14 patients treated with Fitostimuline® 3 times a day, until the lesion disappeared.G3: (Laser) 14 patients treated with LLLT (Low Level Laser Therapy). G4: (Laser + Fitostimuline®) 15 patients treated with LLLT application and Fitostimuline® 3 times per day, until the lesion healed completely. ANOVA was applied for parametric data, and non-parametric ANOVA (Kruskal-Wallis test - Friedman) and Mann-Whitney U test were made. Past statistical software version 2010 for Excel was used. Results: Higher diameter aphthous ulcer measures and pain significantly reduced for the Fitostimuline Gel®and Laser treated groups or both combined if compared with the control group. The medicament effect its slow if compared to laser therapy, nonetheless when used simultaneously the effect does not differ from the one obtained by laser only application. Fitostimuline Gel® application does not increase laser effect on healing. Conclusions: Topical Fitostimuline Gel® and LLLT therapy are highly efficient treatment options for aphthous ulcer and pain generated by orthodontic treatment, when compared to a control group. LLLT therapy, it’s more effective than Fitostimuline Gel® for orthodontic related aphthous ulcer treatment. Combining therapies do not improve nor enhance treatment results.