Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
NCT07402720

Clinical Effectiveness Of Polishing Brush Compared To Ceramic Soft Tissue Trimming Bur In Gingival Depigmentation

Led by Cairo University · Updated on 2026-02-12

20

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical Effectiveness Of Polishing Brush Compared To Ceramic Soft Tissue Trimming Bur In Gingival Depigmentation

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of melanin hyperpigmentation with a pigmentation index of 2 or higher
  • Bilateral gingival pigmentation covering at least three teeth in each arch
  • Age between 18 and 40 years
  • Non-smoker or smoking fewer than 10 cigarettes per day
  • Systemically healthy
  • Willingness to participate and able to sign informed consent
  • Available for all follow-up appointments
  • No previous periodontal surgery in the treatment area except prophylaxis
Not Eligible

You will not qualify if you...

  • Systemic health conditions affecting healing such as diabetes or immune disorders
  • Pregnant or breastfeeding women
  • Heavy smokers
  • Currently undergoing orthodontic treatment in the affected gum area
  • Use of medications that affect the gums, such as phenytoin, cyclosporine, or calcium channel blockers
  • Poor oral hygiene at the start of the study
  • Presence of active periodontal pockets larger than 3 mm or clinical attachment loss
  • Allergy to local anesthetics or materials used in this procedure
  • History of alcohol or drug abuse
  • Psychological conditions that might affect study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

R

Raghad Hamadh, Bachelor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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