Fully Digital Guided Gingivectomy in Management of Gummy Smile: Evaluation of Accuracy and Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Accuracy of both guides
研究概览
简要总结
The goal of this randomized controlled clinical study is to compare Fully digital to conventional guided Gingivectomy procedure in management of excessive gingival display caused by altered passive eruption type 1A.
The main question it aims to answer is:
Does the fully digital guided gingivectomy approach able to introduce a more precise, accuracy and reliability technique with more patient satisfaction compared to the conventional guided method?
详细描述
Nowadays, the concept of smile and dental esthetics is no longer limited to the teeth. The essentials of a smile involve the relationship between the three primary components: the teeth, lip framework, and the gingival scaffold.
The term "pink aesthetics" refers to the aesthetics of gingival tissues, which play a significant influence in smile aesthetics.
Excessive gingival display while smiling, also usually known as a "gummy smile," is a common esthetic concern among dental patients and, being largely viewed as unesthetic, leads many patients to seek some form of treatment to address the issue.
Gummy smile (Excessive gingival display) is recognized by the American Academy of Periodontology (AAP) as a deformity and mucogingival condition that affects the area around the teeth.
This condition could be caused by many etiological factors: short lip, hypermobile/hyperactive lip, short clinical crowns, dentoalveolar extrusion, altered passive eruption (APE), gingival hyperplasia, and vertical maxillary excess.
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)
盲法说明
The current investigation will be a single-blinded clinical trial. Blinding included the assessor, and the statistician. Its impossible for the operator who performed the surgical procedure to be blinded as the interventions will be completely different and the patient also.
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
- •Patients complaining of Excessive gingival display (3mm or more gingival display at full smiling)
- •Patients classified as Altered Passive Eruption Type 1A
排除标准
- •Patients need restorative or orthodontic correction.
- •Pregnant and lactating females.
- •Heavy smoker ≥ 10 cigarettes/day.
- •Poor oral hygiene.
- •Patients with systemic diseases which could influence the outcome of the therapy e.g.
- •(Diabetic patients).
- •Heavy smoker ≥ 10 cigarettes/day.
- •Vulnerable groups of patients e.g. (prisoners, handicapped patients and decisionally impaired individuals)
研究组 & 干预措施
Digital workflow-based Protocol
Fully digital guided gingivectomy procedure
干预措施: Fully digital guided gingivectomy procedure (Procedure)
Mock-up workflow-based Protocol
Convectional guided gingivectomy procedure
干预措施: Convectional guided gingivectomy procedure (Procedure)
结局指标
主要结局
Accuracy of both guides
时间窗: Immediately postsurgical, 4 weeks and 2 months after surgery
Intraoral digital scanning for obtaining gingival contour will be made immediately postsurgical, 4 weeks and 2 months after surgery and exported in STL files format. Diagnostic waxing-up on poured cast (for group 2) will be digitalized with a model scanner and exported in STL file format. Accuracy will be evaluated by: * Superimposing postoperative intraoral digital scanning STL files with virtually designed diagnostic waxing STL file (for group 1) and obtain matching differences in height of gingival margin in relation to Muco-gingival junction. * Superimposing postoperative intraoral digital scanning STL files with digitized waxing-up STL file (for group 2) and obtain matching differences in height of gingival margin in relation to Muco-gingival junction.
次要结局
- Patient Satisfaction(2 months)
研究者
Eslam Hashem
Master Student
Ain Shams University