Ceramic soft tissue trimming bur gingival depigmentation: clinical performance and patient experience. A split mouth randomized controlled trial.

ABSTRACT

BACKGROUND: The ceramic soft tissue trimming bur (CeraTip™) was initially introduced for use in gingivoplasty but has recently been used for gingival depigmentation. The aim of this study is to compare the efficacy of depigmentation between the novel CeraTip™ and the gold-standard surgical scalpel technique. METHODS: Eight healthy, nonsmokers with moderate to severe gingival hyperpigmentation in both arches were randomly assigned for CeraTip™ depigmentation in one arch as the test group (TG) and scalpel depigmentation in the opposite arch as the control group (CG). Pigmentation indices were used to assess clinical performance. Treatment time, pain level, and esthetic satisfaction were the parameters of patient experience. The assessments were performed at baseline, one week, one month, and three months. RESULTS: At all assessment visits, pigmentation intensity represented by the Dummet oral pigmentation index (DOPI), and pigmentation distribution represented by the Hedin melanin index (MI), were significantly lower than those at baseline (p < 0.001) in both groups. When comparing the two groups, Scalpel depigmentation had better initial clinical outcomes, while CeraTip™ had less visible repigmentation, pain scores, treatment time, and greater esthetic satisfaction. However, none of the differences were statistically significant. CONCLUSION: Both techniques successfully removed gingival hyperpigmentation with comparable clinical performance. The patients preferred CeraTip™ depigmentation. 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).