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

NCT07402720 | Recruiting

• 1 other identifier: 2026PER3-3-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Hyperpigmentation

Keywords

ceramic bur; polishing brush; gingival hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• gingival pigmentation intensity

  Dummett Oral Pigmentation Index (DOPI). This is an ordinal index that categorizes pigmentation on a 4-point scale: 0 = no pigmentation, 1 = mild, 2 = moderate, and 3 = heavy pigmentation.

  Baseline, 1 Week, 1 month and at 3 months

Secondary Outcomes (6)

• Patient Satisfaction

  At Baseline, and at 3 months.

• Operating Time

  Perioperative. From the start of the depigmentation procedure until the end of hemostasis and final inspection.

• Pain Perception

  Day 1, Day 3, 1 week, Day 10

• Extent of Pigmentation

  Baseline, 1 Week, 1 month and at 3 months

• Wound Healing

  1 week, 3 months

Study Arms (2)

Polishing brush

ACTIVE COMPARATOR

In the test group, gingival depigmentation will be performed using a polishing brush specifically adapted for soft tissue application. After administering local anesthesia, a silicon carbide or rubber-based polishing brush will be attached to a low-speed handpiece. The pigmented gingival epithelium will be gently abraded in a circular motion under light pressure until the superficial pigmented layer is removed and uniform pink gingiva is visible. Continuous irrigation with sterile saline will be used to prevent heat generation and ensure visibility. The operator will take care not to injure the underlying connective tissue. No periodontal dressing will be applied. Postoperative instructions will include gentle oral hygiene, avoiding hot or spicy foods, and use of 0.12% chlorhexidine mouthwash for 1 week.

Procedure: Gingival Depigmentation using polishing brush

Ceramic bur

EXPERIMENTAL

In the control group, ceramic soft tissue trimming burs will be used to perform gingival depigmentation. After achieving local anesthesia, a flame- or round-shaped ceramic bur will be attached to a low-speed contra-angle handpiece. The bur will be used in a brushing motion to carefully remove the pigmented epithelial layer without applying excessive pressure. The clinician will maintain light, controlled strokes to avoid damaging the underlying lamina propria. As with the polishing brush technique, continuous irrigation with saline will be provided to cool the tissue and improve visibility. Once the pigmented areas are cleared and a healthy pink gingival color is achieved, the procedure will be concluded without any periodontal dressing. Postoperative care will follow the same protocol as the polishing brush group.

Procedure: Depigmentation using ceramic soft tissue trimming bur

Interventions

Depigmentation using ceramic soft tissue trimming bur PROCEDURE

ceramic soft tissue trimming burs will be used to perform gingival depigmentation. After achieving local anesthesia, a flame- or round-shaped ceramic bur will be attached to a low-speed contra-angle handpiece. The bur will be used in a brushing motion to carefully remove the pigmented epithelial layer without applying excessive pressure. The clinician will maintain light, controlled strokes to avoid damaging the underlying lamina propria. As with the polishing brush technique, continuous irrigation with saline will be provided to cool the tissue and improve visibility. Once the pigmented areas are cleared and a healthy pink gingival color is achieved, the procedure will be concluded without any periodontal dressing. Postoperative care will follow the same protocol as the polishing brush group.

Ceramic bur

Gingival Depigmentation using polishing brush PROCEDURE

gingival depigmentation will be performed using a polishing brush specifically adapted for soft tissue application. After administering local anesthesia, a silicon carbide or rubber-based polishing brush will be attached to a low-speed handpiece. The pigmented gingival epithelium will be gently abraded in a circular motion under light pressure until the superficial pigmented layer is removed and uniform pink gingiva is visible. Continuous irrigation with sterile saline will be used to prevent heat generation and ensure visibility. The operator will take care not to injure the underlying connective tissue. No periodontal dressing will be applied. Postoperative instructions will include gentle oral hygiene, avoiding hot or spicy foods, and use of 0.12% chlorhexidine mouthwash for 1 week.

Polishing brush

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Study Officials

• Mona Darhous, Professor

  Cairo Univeristy

  STUDY DIRECTOR

• Maie Esmaiel, Lecturer

  Cairo University

  STUDY CHAIR

• Raghad Hamadh, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raghad Hamadh, Bachelor

CONTACT

+201016602933; raghad.hisham@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Raghad Hisham

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 11, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

EG (1)