Comparison of Er-YAG Laser, Air Polishing, and Surgical Excision for Gingival Hyperpigmentation (APGH)
26 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
24
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Atakum
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Samsun, Atakum, Turquie (Türkiye), 55200
- Ondokuz Mayıs University Faculty of Dentistry
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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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.
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Expérimental: 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.
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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.
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|
Expérimental: 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.
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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.
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Comparateur actif: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in RGB Color Values
Délai: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
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Changes in gingival color will be quantitatively assessed using standardized digital photographs and RGB color analysis following depigmentation procedures.
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Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
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Color Difference (Delta E)
Délai: 7 days after treatment, 1 month after treatment, and 3 months after treatment
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Gingival color change following treatment will be evaluated by calculating color difference values using the Delta E (CIE76) formula based on digital photographic analysis.
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7 days after treatment, 1 month after treatment, and 3 months after treatment
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Change in Pigmented Area
Délai: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
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The extent of gingival pigmentation will be quantitatively assessed by measuring the pigmented gingival area from standardized digital photographs.
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Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
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Change in Dummett Oral Pigmentation Index (DOPI)
Délai: Baseline, 1 months after treatment, 3 months after treatment
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Gingival pigmentation intensity will be clinically evaluated using the Dummett Oral Pigmentation Index (DOPI) to assess treatment effectiveness.
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Baseline, 1 months after treatment, 3 months after treatment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postoperative Pain Level
Délai: Day 1 after treatment, Day 3 after treatment, and Day 7 after treatment
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Postoperative pain associated with each treatment procedure will be assessed using the Visual Analog Scale (VAS).
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Day 1 after treatment, Day 3 after treatment, and Day 7 after treatment
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Patient Esthetic Satisfaction
Délai: Baseline, 3 months after treatment
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Patient satisfaction regarding esthetic treatment outcomes will be evaluated using a Visual Analog Scale (VAS).
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Baseline, 3 months after treatment
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Clinician Esthetic Evaluation
Délai: Baseline, 1 months after treatment, 3 months after treatment
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Esthetic treatment outcomes will be independently evaluated by blinded clinicians to assess overall esthetic improvement after treatment.
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Baseline, 1 months after treatment, 3 months after treatment
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 décembre 2025
Achèvement primaire (Réel)
1 juin 2026
Achèvement de l'étude (Réel)
1 juin 2026
Dates d'inscription aux études
Première soumission
21 juin 2026
Première soumission répondant aux critères de contrôle qualité
26 juin 2026
Première publication (Réel)
29 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- OMU-KAEK-2025/1248
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .