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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Gingival Depigmentation using polishing brush
Procedure/Surgerygingival depigmentation will be performed using a polishing brush specifically adapted for soft tissue application. After administering local anesthesia, a silicon carbide or rubber-based polishing brush will be attached to a low-speed handpiece. The pigmented gingival epithelium will be gently abraded in a circular motion under light pressure until the superficial pigmented layer is removed and uniform pink gingiva is visible. Continuous irrigation with sterile saline will be used to prevent heat generation and ensure visibility. The operator will take care not to injure the underlying connective tissue. No periodontal dressing will be applied. Postoperative instructions will include gentle oral hygiene, avoiding hot or spicy foods, and use of 0.12% chlorhexidine mouthwash for 1 week.
Depigmentation using ceramic soft tissue trimming bur
Procedure/Surgeryceramic soft tissue trimming burs will be used to perform gingival depigmentation. After achieving local anesthesia, a flame- or round-shaped ceramic bur will be attached to a low-speed contra-angle handpiece. The bur will be used in a brushing motion to carefully remove the pigmented epithelial layer without applying excessive pressure. The clinician will maintain light, controlled strokes to avoid damaging the underlying lamina propria. As with the polishing brush technique, continuous irrigation with saline will be provided to cool the tissue and improve visibility. Once the pigmented areas are cleared and a healthy pink gingival color is achieved, the procedure will be concluded without any periodontal dressing. Postoperative care will follow the same protocol as the polishing brush group.
Treatment groups
Trial outcomes
Primary outcomes
gingival pigmentation intensity
Dummett Oral Pigmentation Index (DOPI). This is an ordinal index that categorizes pigmentation on a 4-point scale: 0 = no pigmentation, 1 = mild, 2 = moderate, and 3 = heavy pigmentation.
Secondary outcomes
Patient Satisfaction
Evaluated using a Visual Analog Score based questionnaire reflecting the Oral Health Related Quality of Life (OHRQoL), adapted from OHIP-1 to OHIP-14, measuring satisfaction with esthetic and functional outcomes following treatment. containing seven first-order factors (dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap) This instrument has a 5-point Likert-type response scale (0: never, 1: hardly ever, 2: occasionally, 3: fairly often, 4: very often).
Operating Time
Measured in minutes using a digital stopwatch from the start of the depigmentation procedure until the end of hemostasis and final inspection.
Pain Perception
Assessed using a Visual Analog Scale (VAS), where participants will rate their pain perception on a continuous scale from 0 (no pain) to 10 (worst imaginable pain).
Extent of Pigmentation
Assessed using the Takashi Index, a 3-grade ordinal scale scoring the extent of pigmentation as follows:0 = no pigmentation, 1 = isolated spots, and 2 = continuous ribbon. This will be recorded at each time point to assess reduction in pigmentation area.
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