Polishing brush versus ceramic soft-tissue trimming bur for gum depigmentation
Clinical Effectiveness Of Polishing Brush Compared to Ceramic Soft Tissue Trimming Bur In Gingival Depigmentation: A Randomized Controlled Trial
This test tries whether a polishing brush or a ceramic soft-tissue trimming bur works better to remove melanin-related dark spots on the gums in healthy adults with moderate-to-severe pigmentation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07402720 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective randomized controlled trial at Cairo University comparing two minimally invasive rotary methods for gingival depigmentation. Eligible, systemically healthy adults with bilateral melanin hyperpigmentation are randomized to receive either depigmentation with a polishing brush or with a ceramic soft-tissue trimming bur applied to both sides of the arch. Randomization is computer-generated and outcome assessors are blinded; the protocol follows CONSORT guidance with standardized baseline and predefined follow-up visits to measure gingival thickness and other soft-tissue outcomes. The trial focuses on clinical healing, postoperative discomfort, and aesthetic outcomes to determine relative effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy, non-heavy-smoking adults (roughly 18–40 years) with bilateral melanin-related gingival pigmentation of at least three teeth per arch, good oral hygiene, and willingness to attend follow-up visits and provide consent.
Not a fit: Patients with systemic conditions that impair healing, heavy smokers, pregnant or lactating women, those on gingiva-altering medications, or those with active periodontal disease are unlikely to benefit or be eligible for this trial.
Why it matters
Potential benefit: If successful, the trial could identify a gentler technique that gives good cosmetic results with less discomfort and faster healing for patients seeking gum depigmentation.
How similar studies have performed: Small case series and early reports have suggested rotary instruments like ceramic burs and polishing brushes can work for depigmentation, but randomized comparative data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * • 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 this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Raghad Hamadh, Bachelor — Cairo University
- Study coordinator: Raghad Hamadh, Bachelor
- Email: raghad.hisham@dentistry.cu.edu.eg
- Phone: +201016602933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.