Comparison of Er-YAG Laser, Air Polishing, and Surgical Excision for Gingival Hyperpigmentation

NCT07672587 | Completed

• 1 other identifier: OMU-KAEK-2025/1248
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aimed to compare the effectiveness of different treatment approaches for physiologic gingival hyperpigmentation. Participants with gingival melanin pigmentation were randomly assigned to one of four treatment groups: Er:YAG laser treatment, air polishing with erythritol powder, air polishing with sodium bicarbonate powder, or conventional surgical excision. Clinical outcomes were evaluated using pigmentation index scores, digital image analysis, and color measurements at baseline and follow-up visits. Patient-centered outcomes, including postoperative discomfort and satisfaction, were also assessed. The study sought to determine whether air polishing techniques could provide clinical outcomes comparable to conventional treatment approaches while improving patient comfort and satisfaction.

Conditions

Gingival Hyperpigmentation; Oral Pigmentation

Keywords

Physiologic Gingival Hyperpigmentation; Air Polishing; Er:YAG Laser; Gingival Depigmentation; Melanin Pigmentation

Outcome Measures

Primary Outcomes (4)

• Change in RGB Color Values

  Changes in gingival color will be quantitatively assessed using standardized digital photographs and RGB color analysis following depigmentation procedures.

  Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment

• Color Difference (Delta E)

  Gingival color change following treatment will be evaluated by calculating color difference values using the Delta E (CIE76) formula based on digital photographic analysis.

  7 days after treatment, 1 month after treatment, and 3 months after treatment

• Change in Pigmented Area

  The extent of gingival pigmentation will be quantitatively assessed by measuring the pigmented gingival area from standardized digital photographs.

  Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment

• Change in Dummett Oral Pigmentation Index (DOPI)

  Gingival pigmentation intensity will be clinically evaluated using the Dummett Oral Pigmentation Index (DOPI) to assess treatment effectiveness.

  Baseline, 1 months after treatment, 3 months after treatment

Secondary Outcomes (3)

• Postoperative Pain Level

  Day 1 after treatment, Day 3 after treatment, and Day 7 after treatment

• Patient Esthetic Satisfaction

  Baseline, 3 months after treatment

• Clinician Esthetic Evaluation

  Baseline, 1 months after treatment, 3 months after treatment

Study Arms (4)

Er:YAG Laser Group

EXPERIMENTAL

Participants assigned to this group received gingival depigmentation treatment using Er:YAG laser for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period.

Procedure: Er:YAG Laser Therapy

Air Polishing Erythritol Group

EXPERIMENTAL

Participants assigned to this group received gingival depigmentation treatment using an air polishing device with erythritol powder for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period.

Procedure: Air Polishing with Erythritol Powder

Air Polishing Sodium Bicarbonate Group

EXPERIMENTAL

Participants assigned to this group received gingival depigmentation treatment using an air polishing device with sodium bicarbonate powder for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period.

Procedure: Air Polishing with Sodium Bicarbonate Powder

Conventional Surgical Excision Group

ACTIVE COMPARATOR

Participants assigned to this group received conventional surgical gingival depigmentation treatment by surgical excision for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period.

Procedure: Conventional Surgical Excision

Interventions

Er:YAG Laser Therapy PROCEDURE

Gingival depigmentation was performed using Er:YAG laser therapy to remove physiologic gingival melanin pigmentation. The procedure was applied according to the manufacturer's recommended clinical protocol for soft tissue ablation.

Er:YAG Laser Group

Air Polishing with Erythritol Powder PROCEDURE

Gingival depigmentation was performed using an air polishing system with erythritol powder to remove physiologic gingival melanin pigmentation. The procedure was carried out by applying pressurized air and powder particles to the pigmented gingival surface according to the treatment protocol.

Air Polishing Erythritol Group

Air Polishing with Sodium Bicarbonate Powder PROCEDURE

Gingival depigmentation was performed using an air polishing system with sodium bicarbonate powder to remove physiologic gingival melanin pigmentation. The procedure was carried out by applying pressurized air and powder particles to the pigmented gingival surface according to the treatment protocol.

Air Polishing Sodium Bicarbonate Group

Conventional Surgical Excision PROCEDURE

Gingival depigmentation was performed using a conventional surgical excision technique for the removal of physiologic gingival melanin pigmentation. The procedure involved surgical removal of the pigmented gingival epithelium using conventional periodontal surgical instruments according to standard clinical practice.

Conventional Surgical Excision Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged between 18 and 50 years
• Systemically healthy individuals
• Presence of physiologic gingival hyperpigmentation in the anterior maxillary or mandibular gingiva
• Individuals seeking esthetic treatment for gingival pigmentation
• Presence of adequate oral hygiene and periodontal health before treatment
• Willingness to participate in the study and provide written informed consent
• Agreement to attend all follow-up visits during the study period

You may not qualify if:

• Presence of systemic diseases or conditions that may affect wound healing
• Smoking or use of tobacco products
• Pregnancy or lactation
• History of periodontal therapy or gingival depigmentation treatment in the study area
• Presence of active periodontal disease or gingival inflammation at baseline
• Use of medications affecting gingival tissues or wound healing
• Individuals with non-physiologic oral pigmentation associated with systemic disorders, medication use, or syndromic conditions
• Inability or unwillingness to comply with study protocol and follow-up visits

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Faculty of Dentistry

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

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, Periodontist

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 29, 2026
• Study Start: December 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)