Gingival Depigmentation Using a 940 nm Diode Laser Versus Ceramic Bur

NCT07841119 | Not Yet Recruiting FDA Device

• 1 other identifier: 2669/QĐ-ĐHYD
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized split-mouth clinical trial will compare the effectiveness of a 940 nm GaAlAs diode laser and a ceramic soft tissue trimmer for the treatment of physiologic gingival melanin pigmentation. Each participant will receive both treatment modalities in separate gingival regions according to a randomized allocation. Changes in gingival pigmentation will be evaluated using clinical pigmentation indices and digital image analysis. Participants will be followed at 1, 3, and 6 months after treatment to assess pigmentation reduction and repigmentation.

Conditions

Physiologic Gingival Melanin Pigmentation

Keywords

Gingival depigmentation; Gingival melanin pigmentation; Diode laser; Ceramic soft tissue trimmer; Split-mouth randomized clinical trial

Outcome Measures

Primary Outcomes (3)

• Change in Dummett Oral Pigmentation Index (DOPI)

  Gingival pigmentation intensity is assessed using the Dummett Oral Pigmentation Index (DOPI), scored from 0 to 3: score 0 = no clinical pigmentation, with pink gingiva; score 1 = mild pigmentation, characterized by light-brown gingiva; score 2 = moderate pigmentation, characterized by medium-brown or mixed pink and brown gingiva; and score 3 = heavy pigmentation, characterized by deep-brown or bluish-black gingiva. Higher scores indicate greater gingival pigmentation intensity. DOPI scores are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer over follow-up.

  Baseline, 1 month, 3 months, and 6 months after treatment

• Change in Pigmented Gingival Area

  The pigmented gingival area is quantified from standardized clinical photographs using digital image analysis and expressed as the percentage of the total gingival area showing melanin pigmentation. Changes are compared between the two treatment modalities over follow-up.

  Baseline, 1 month, 3 months, and 6 months after treatment

• Extent of Gingival Pigmentation According to the Ponnaiyan Classification

  The extent and distribution of gingival melanin pigmentation are assessed according to the Ponnaiyan classification (2013), which categorizes pigmentation into six types based on the gingival areas involved: Type I, pigmentation limited to the attached gingiva; Type II, pigmentation involving the attached gingiva and interdental papillae; Type III, pigmentation involving the attached gingiva, marginal gingiva, and interdental papillae; Type IV, pigmentation limited to the marginal gingiva; Type V, pigmentation limited to the interdental papillae; and Type VI, pigmentation involving the marginal gingiva and interdental papillae. Changes in Ponnaiyan classification are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer during follow-up.

  Baseline, 1 month, 3 months, and 6 months after treatment

Secondary Outcomes (8)

• Surgical Procedure Time

  During the surgical procedure

• Perioperative Bleeding

  During the surgical procedure and 1 day after treatment

• Postoperative Pain

  1, 3, and 7 days after treatment

• Gingival Epithelialization

  3 and 7 days after treatment

• Patient Satisfaction

  6 months after treatment

Study Arms (2)

Laser group

EXPERIMENTAL

Gingival depigmentation is performed in one randomly assigned gingival region using a 940 nm GaAlAs diode laser (EpicX, Biolase).

Device: 940 nm GaAlAs Diode Laser

Ceramic Bur Group

ACTIVE COMPARATOR

Gingival depigmentation is performed in the contralateral gingival region using a ceramic soft tissue trimmer (NTI).

Device: Ceramic Soft Tissue Trimmer

Interventions

940 nm GaAlAs Diode Laser DEVICE

Gingival depigmentation is performed using a 940 nm GaAlAs diode laser (EPIC X, BIOLASE) according to the study protocol.

Also known as: EPIC X (BIOLASE)

Laser group

Ceramic Soft Tissue Trimmer DEVICE

Gingival depigmentation is performed using a ceramic soft tissue trimmer (NTI) according to the study protocol.

Also known as: NTI Tissue Trimmer

Ceramic Bur Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older.
• Periodontal health, with gingival index (GI) ≤1, bleeding on probing (BOP) ≤10%, probing depths ≤3 mm, and no periodontitis.
• Thick gingival phenotype with moderate to severe physiologic melanin pigmentation, corresponding to DOPI scores of 2-3, affecting the facial gingiva of the anterior and premolar regions bilaterally.
• Good oral hygiene, with plaque index (PI) ≤1 and calculus index (CI) ≤1.

You may not qualify if:

• Thin gingival phenotype at the treatment sites.
• Uncontrolled systemic diseases, including cardiovascular disease, hypertension, or diabetes mellitus.
• Pregnancy or lactation.
• Use of medications or presence of conditions affecting hemostasis or wound healing.
• Oral pigmentation attributable to causes other than physiologic melanin pigmentation, including metallic pigmentation, amalgam tattoo, traumatic tattoo, or pigmentation associated with malignant conditions.
• Use of medications or chemical agents known to induce oral pigmentation, including antimalarial drugs, minocycline, ketoconazole, or oral contraceptives.
• Current smoking.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh City, 749000, Vietnam

Location

Central Study Contacts

Huy Gia Ho, DDS

CONTACT

+84942560496; ghuygl@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor is blinded to the intervention allocation and is not involved in the treatment procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident, Department of Periodontics, Faculty of Dentistry

Model Details: This study uses a randomized split-mouth design. Each participant receives both interventions in paired contralateral gingival regions. One region is randomly assigned to treatment with a 940 nm diode laser, while the contralateral region is treated with a ceramic soft tissue trimmer.

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 25, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)