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

Comparison of Laser, Guided Biofilm Therapy, and Conventional Surgical Approaches in the Treatment of Gingival Hyperpigmentation: Evaluation of Clinical Outcomes and Patient Satisfaction

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.

Study Overview

• Status: Completed
• Conditions: Gingival Hyperpigmentation; Oral Pigmentation
• Intervention / Treatment: Procedure: Er:YAG Laser Therapy; Procedure: Air Polishing with Erythritol Powder; Procedure: Air Polishing with Sodium Bicarbonate Powder; Procedure: Conventional Surgical Excision

Detailed Description

Physiologic gingival hyperpigmentation is a common esthetic condition caused by excessive melanin deposition within the gingival epithelium. Several treatment approaches have been proposed to eliminate gingival pigmentation, including conventional surgical techniques, laser applications, and minimally invasive air polishing systems. Although conventional surgical excision and laser therapy are widely used, alternative approaches that may reduce postoperative discomfort while maintaining comparable clinical outcomes remain of clinical interest.

The purpose of this randomized controlled clinical trial was to compare the clinical effectiveness and patient-related outcomes of four different treatment modalities for gingival hyperpigmentation: Er:YAG laser treatment, air polishing with erythritol powder, air polishing with sodium bicarbonate powder, and conventional surgical excision.

Eligible participants diagnosed with physiologic gingival melanin hyperpigmentation were randomly allocated into four parallel treatment groups. Clinical pigmentation changes were assessed using standardized clinical photographs, pigmentation index scoring systems, digital color analysis, and quantitative color measurements during baseline and follow-up examinations over a three-month period. Secondary evaluations included postoperative discomfort assessment and patient satisfaction measurements.

The study was designed to evaluate whether minimally invasive air polishing approaches could achieve clinical outcomes comparable to established treatment methods while providing improved patient comfort during the healing period.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Atakum
    • Samsun, Atakum, Turkey (Türkiye), 55200
      • Ondokuz Mayıs University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Er:YAG Laser Group; 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; 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.
Experimental: Air Polishing Erythritol Group; 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; 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.
Experimental: Air Polishing Sodium Bicarbonate Group; 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; 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.
Active Comparator: Conventional Surgical Excision Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Level	Postoperative pain associated with each treatment procedure will be assessed using the Visual Analog Scale (VAS).	Day 1 after treatment, Day 3 after treatment, and Day 7 after treatment
Patient Esthetic Satisfaction	Patient satisfaction regarding esthetic treatment outcomes will be evaluated using a Visual Analog Scale (VAS).	Baseline, 3 months after treatment
Clinician Esthetic Evaluation	Esthetic treatment outcomes will be independently evaluated by blinded clinicians to assess overall esthetic improvement after treatment.	Baseline, 1 months after treatment, 3 months after treatment

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Actual): June 1, 2026
• Study Completion (Actual): June 1, 2026

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Er:YAG Laser; Air Polishing; Physiologic Gingival Hyperpigmentation; Gingival Depigmentation; Melanin Pigmentation
• Other Study ID Numbers: OMU-KAEK-2025/1248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data generated during this study will not be publicly shared because no formal data-sharing plan has been established and the study was conducted as part of an institutional academic research project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No