Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- clinical outcomes of depigmentation procedure
研究概览
简要总结
the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery
详细描述
This clinical study will be carried out to compare the efficacy of ceramic soft tissue trimming bur versus the conventional surgical scraping technique in the management of gingival hyperpigmentation.
This study will be conducted to assess:
Primary objectives:
- Clinical outcome of the gingival depigmentation procedure.
- Assessment of postoperative pain using the visual analogue scale.
- Patients' satisfaction will be assessed using the patient satisfaction questionnaire (short-form, PSQ-18) and the global aesthetic improvement scale.
Secondary objectives:
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females within age range of 20-50 years.
- •Systemic (medically) free individuals.
- •Gingival pigmentation score > 3 on Hedin melanin index
- •Patients with good oral hygiene.
- •Patients with thick gingival phenotype.
排除标准
- •Teeth with compromised periodontium.
- •Pregnant and lactating females.
- •The vulnerable group: patients with mental or physical disabilities.
- •Medications that cause gingival pigmentation.
- •Pathologies that cause gingival pigmentation.
结局指标
主要结局
clinical outcomes of depigmentation procedure
时间窗: 3 month postoperative
dummet oral pigmentation index ( DOPI): 1= pink no pigmentation (better) 4= deep brown (worse) Melanin index (MI):1= isolated pigment (better), 4= long continous ribbon (worse). reported by visual inspection.
patient satisfaction
时间窗: 3 months postoperative
global aesthetic improvement scale 5 point likert scale 1= excellent improvement 5= worsened. patient reported outcome. a score from 1 to 5, 1 being better
Percieved pain
时间窗: 7 days
postoperative pain will be assessed using visual analoque scale (VAS): 1= being the least pain and 10= being the most severe
次要结局
- operating time(during surgery)
- Wound healing(7 days postoperative)
研究者
Sally Nassar
Dentist
Ain Shams University