Comparison of Laser, Guided Biofilm Therapy, and Conventional Surgical Approaches in the Treatment of Gingival Hyperpigmentation: Evaluation of Clinical Outcomes and Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in RGB Color Values
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Er:YAG Laser Therapy (Procedure)
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.
干预措施: Air Polishing with Erythritol Powder (Procedure)
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.
干预措施: Air Polishing with Sodium Bicarbonate Powder (Procedure)
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.
干预措施: Conventional Surgical Excision (Procedure)
结局指标
主要结局
Change in RGB Color Values
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Postoperative Pain Level(Day 1 after treatment, Day 3 after treatment, and Day 7 after treatment)
- Patient Esthetic Satisfaction(Baseline, 3 months after treatment)
- Clinician Esthetic Evaluation(Baseline, 1 months after treatment, 3 months after treatment)
研究者
Nermin Arslan
Principal Investigator, Periodontist
Ondokuz Mayıs University