About this trial
Gingival hyperpigmentation, particularly of melanin origin, can pose significant aesthetic concerns, especially among patients with a high smile line. Several depigmentation techniques have been proposed to manage this condition, including scalpel surgery, electrosurgery, cryotherapy, lasers, and various rotary instruments. Recently, minimally invasive rotary tools such as ceramic burs and polishing brushes have gained interest due to their potential to deliver controlled ablation with reduced postoperative discomfort and healing complications.
Ceramic soft tissue trimming burs are specially designed to remove superficial pigmented gingival layers with minimal trauma. However, these instruments may still generate heat and cause a degree of tissue damage. On the other hand, polishing brushes, traditionally used for surface finishing and stain removal, have recently been explored for soft tissue applications due to their gentle action and adaptability.
Despite their increasing use, there is insufficient comparative clinical evidence on the efficacy, healing outcomes, and patient-centered experiences between these two modalities in gingival depigmentation. A split-mouth randomized controlled trial design offers the advantage of eliminating inter-individual variability. Thus, this study aims to assess and compare the clinical effectiveness of the polishing brush and ceramic trimming bur for gingival depigmentation in terms of pigment reduction, healing outcomes, postoperative pain, and recurrence.
Eligibility criteria
Qualifiers
Presence of melanin hyperpigmentation (Dummett Oral Pigmentation Index ≥ 2)
Presence of bilateral gingival pigmentation extending at least 3 teeth in each arch
Age range: e.g., 18-40 years (adjust based on your sample)
Non-smokers (or smokers <10 cigarettes/day, specify if allowed)
Disqualifiers
• Systemic conditions affecting healing (e.g., diabetes mellitus,immunosuppressive disorders)
Pregnant or lactating women
Heavy Smokers
Ongoing orthodontic treatment in the affected area
Trial design
Treatments tested in this trial
- Gingival Depigmentation using polishing brush
- Depigmentation using ceramic soft tissue trimming bur