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

26. juni 2026 opdateret af: Nermin Arslan, Ondokuz Mayıs University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Eksperimentel: 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.
Eksperimentel: 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.
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in RGB Color Values
Tidsramme: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
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)
Tidsramme: 7 days after treatment, 1 month after treatment, and 3 months after treatment
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
Tidsramme: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
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)
Tidsramme: Baseline, 1 months after treatment, 3 months after treatment
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Pain Level
Tidsramme: Day 1 after treatment, Day 3 after treatment, and Day 7 after treatment
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
Tidsramme: Baseline, 3 months after treatment
Patient satisfaction regarding esthetic treatment outcomes will be evaluated using a Visual Analog Scale (VAS).
Baseline, 3 months after treatment
Clinician Esthetic Evaluation
Tidsramme: Baseline, 1 months after treatment, 3 months after treatment
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ondokuz Mayıs University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2025

Primær færdiggørelse (Faktiske)

1. juni 2026

Studieafslutning (Faktiske)

1. juni 2026

Datoer for studieregistrering

Først indsendt

21. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • OMU-KAEK-2025/1248

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Gingival Hyperpigmentering

Kliniske forsøg med Er:YAG Laser Therapy

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