Evaluation of the Efficacy of Applying the Nano-crystalline Silver Membrane After Surgical Gingival Depigmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Wound Healing: Clinical Tissue Healing Index
研究概览
简要总结
Silver compounds have demonstrated a positive effect in most medical fields, including periodontal therapy, particularly in their nano-formulations. These nanoparticles have exhibited a significant capacity to accelerate healing and possess antibacterial and anti-inflammatory properties, in addition to their ability to mitigate pain and postoperative complications.
详细描述
The objective of the current study was to evaluate tissue healing, epithelialization, postoperative pain, degree of pigmentation, and patient satisfaction following the application of a nano-silver crystal membrane compared to conventional dressing after the surgical removal of gingival melanin pigmentation.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gingival Hyperpigmentation: Presence of physiological melanin pigmentation in the maxillary anterior region, categorized as Grade 3 or 4 according to the Heden Gingival Pigmentation Index.
- •Age Demographic: Patients aged 20 years or older.
- •Periodontal Health: Absence of active periodontal disease (e.g., periodontitis or gingivitis).
- •Gingival Biotype: Presence of a medium-to-thick gingival biotype.
- •Attached Gingiva: An adequate width of attached gingiva to ensure surgical stability.
- •Oral Hygiene: Demonstration of good oral hygiene with a proven ability to maintain effective plaque control throughout the study period.
排除标准
- •Systemic Pigmentation: Presence of gingival discoloration secondary to systemic conditions or metabolic disorders.
- •Drug-Induced Pigmentation: Hyperpigmentation resulting from the administration of specific pharmacological agents.
- •Poor Oral Hygiene: Inadequate plaque control or a lack of compliance with oral self-care instructions.
- •Smoking Status: Current smokers or individuals with a recent history of tobacco use, due to its confounding effect on gingival pigmentation and wound healing.
- •Physiological Status: Pregnant or lactating women.
- •Systemic Health & Medication: Patients with underlying systemic diseases or those receiving medications known to influence periodontal tissue integrity or inflammatory response (e.g., immunosuppressants or calcium channel blockers).
- •Periodontal Disease: Presence of active periodontitis or attachment loss.
研究组 & 干预措施
Standard Coe-PAK dressing
De-epithelialization of the melanin-pigmented gingiva was executed with a surgical blade, and the site was covered with the Coe-Pak dressing.
干预措施: Non eugenol zinc oxide Dressing (Procedure)
Nano Silver dressing
De-epithelialization of the melanin-pigmented gingiva was executed with a surgical blade, and the site was covered with the Nano Silver dressing.
干预措施: Nano Silver Dressing (Procedure)
结局指标
主要结局
Wound Healing: Clinical Tissue Healing Index
时间窗: Measured weekly, one week postoperatively until week 4 (measured 4 times).
The Tissue Healing Index was evaluated weekly for a total of four weeks postoperatively, according to the following five grades: * Grade 1 (Very Poor): Redness (\>50%), granulation, bleeding, and pus present. * Grade 2 (Poor): Redness (\>50%), granulation, and bleeding present; no pus. * Grade 3 (Good): Redness (\<50%), no granulation, no bleeding, and no exposed connective tissue. * Grade 4 (Very Good): Redness (\<25%), no granulation, no bleeding, and no exposed connective tissue. * Grade 5 (Excellent): Healthy pink tissue, no bleeding, and complete marginal closure.
Epithelization: Clinical epithelialization Index
时间窗: Measured weekly, one week postoperatively until week 4 (measured 4 times).
Re-epithelialization was assessed weekly for a total of four weeks postoperatively using 1% Toluidine Blue. Deep blue staining identifies denuded connective tissue, while pale blue indicates complete healing. The clinical scale is as follows: * Grade 1: No epithelial formation. * Grade 2: Partial coverage (less than 50%). * Grade 3: Substantial coverage (more than 50%). * Grade 4: Complete re-epithelialization.
次要结局
- Pain Assessment and Analgesic Consumption(Measured daily from day 1 till day 7 postoperatively.)
- Patient Satisfaction Index (PSI)(recorded for one time one week after the procedure was done)