Gingival Hyperpigmentation, Oral Pigmentation
Conditions
Keywords
Physiologic Gingival Hyperpigmentation, Air Polishing, Er:YAG Laser, Gingival Depigmentation, Melanin Pigmentation
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.
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.
Interventions
PROCEDUREEr: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.
PROCEDUREAir 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.
PROCEDUREAir 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.
PROCEDUREConventional 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.
Sponsors
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in RGB Color Values | 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. |
| Color Difference (Delta E) | 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. |
| Change in Pigmented Area | 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. |
| Change in Dummett Oral Pigmentation Index (DOPI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Level | 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). |
| Patient Esthetic Satisfaction | Baseline, 3 months after treatment | Patient satisfaction regarding esthetic treatment outcomes will be evaluated using a Visual Analog Scale (VAS). |
| Clinician Esthetic Evaluation | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed