Ceramic Soft Tissue Trimming Bur Gingival Depigmentation: Clinical Performance and Patient Experience. “A Split Mouth Randomized Controlled Trial”

Abstract

Background Ceramic soft tissue trimming bur (Cerabur) was primarily launched to be used in gingivoplasty but has been used recently in gingival depigmentation. This study aimed to compare the efficacy of depigmentation using the novel cerabur versus the gold-standard surgical scalpel technique. Methods Eight healthy, non-smokers with moderate to severe gingival hyperpigmentation in both arches were randomly assigned for cerabur depigmentation in one arch as a test group (TG) and scalpel depigmentation in the opposite arch as a control group (CG). Pigmentation indices were used to assess the clinical outcome. Treatment time, pain levels, and esthetic satisfaction were the parameters of patient experience. The assessment was done at baseline, 1 week, 1 month, and 3 months. Results At all the assessment visits, the pigmentation intensity represented by Dummet oral pigmentation index (DOPI), and distribution represented by Hedin melanin index (MI) were significantly less than baseline (p < 0.001) in both groups. When comparing both groups, Scalpel depigmentation had better initial clinical outcomes, while Cerabur had less visible re-pigmentation, pain Scores, and treatment time, along with more esthetic satisfaction. However, all these differences were not statistically significant. Conclusion Both techniques successfully removed the gingival hyperpigmentation with comparable clinical outcomes. Cerabur depigmentation was favored by the patients. Trial registration: The study protocol was registered on 11/09/2023 on the www.clinicaltrials.gov database (NCT06031116) after the approval of the Ethics Committee, Faculty of Dentistry, Ain Shams University (FDASU-Rec012124).