Polishing brush versus ceramic soft-tissue trimming bur for gum depigmentation
Official title: Clinical Effectiveness Of Polishing Brush Compared to Ceramic Soft Tissue Trimming Bur In Gingival Depigmentation: A Randomized Controlled Trial
Run by Cairo University · NCT07402720 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT07402720 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.