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

26 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

24

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.
Sperimentale: 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.
Procedura: 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.
Sperimentale: 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.
Procedura: 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.
Comparatore attivo: 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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in RGB Color Values
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative Pain Level
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ondokuz Mayıs University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2025

Completamento primario (Effettivo)

1 giugno 2026

Completamento dello studio (Effettivo)

1 giugno 2026

Date di iscrizione allo studio

Primo inviato

21 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

29 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • OMU-KAEK-2025/1248

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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