Clinical Effectiveness Of Polishing Brush Compared To Ceramic Soft Tissue Trimming Bur In Gingival Depigmentation
Recruiting now · Not applicable
Conditions studied: Gingival Hyperpigmentation
In brief
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.
Key facts
- Study ID
- NCT07402720
- Run by
- Cairo University
- People needed
- 20
- Starts
- 2025-11-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- Systemically healthy
- Willingness to participate and sign informed consent 8
- Available for follow-up appointments
- No previous periodontal surgery in the area other than prophylaxis
You may not qualify if…
- • Systemic conditions affecting healing (e.g., diabetes mellitus,immunosuppressive disorders)
- Pregnant or lactating women
- Heavy Smokers
- Ongoing orthodontic treatment in the affected area
- Use of medications affecting gingiva (e.g., phenytoin, cyclosporine, calcium channel blockers)
- Poor oral hygiene at baseline
- Active periodontal pockets >3 mm or clinical attachment loss
- Allergy to local anesthetics or materials used in the procedure
- History of alcohol or drug abuse
- Psychological conditions that may interfere with compliance
Where it is running
- Cairo University — Cairo, Egypt (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.