NCT07402720 Clinical Effectiveness Of Polishing Brush Compared To Ceramic Soft Tissue Trimming Bur In Gingival Depigmentation
| NCT ID | NCT07402720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Gingival Hyperpigmentation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-11-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Mona Darhous, Professor
STUDY DIRECTOR
Cairo Univeristy
Frequently Asked Questions
Who can join the NCT07402720 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Gingival Hyperpigmentation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07402720 currently recruiting?
Yes, NCT07402720 is actively recruiting participants. Contact the research team at raghad.hisham@dentistry.cu.edu.eg for enrollment information.
Where is the NCT07402720 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07402720 clinical trial?
NCT07402720 is sponsored by Cairo University. The principal investigator is Mona Darhous, Professor at Cairo Univeristy. The trial plans to enroll 20 participants.