Crown Lengthening in Aesthetic Anterior Sector by Means of Guided Digital Planning: 12-month Randomized Controlled Clinical Trial Comparing the Efficacy of Digital Versus Analog Protocol.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- The accuracy of surgical guide.
研究概览
简要总结
The objective of this research is to compare the diagnostic accuracy in the detection of the cementoenamel junction (CEJ) and alveolar bone ridge using guided digital planning versus conventional analog planning for patients with excessive gingival exposure in the smile (gummy smile) due, at least in part, to altered passive eruption.
详细描述
Forty-four subjects will be randomly assigned to the planning groups according to a digital methodology, DM (n=22) or an analog methodology AM (n=22). Surgical guides will be developed to establish the location of the acementoenamel junction and bone crest. The digital methodology will consist of obtaining a digital scan and a computed tomography (CBCT) that will be aligned using a digital program for the elaboration of a digital wax-up and fabrication of a printed surgical template. The analog wax-up will be elaborated based on a silicone impression and periapical radiographs with parallel technique, which will allow us to elaborate an essix type surgical splint. Measurements will be recorded at baseline, on the day of surgery, at 4, 6 and 12 months of follow-up. Variables related to the patient's experience will also be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age
- •Presence of teeth in the second sextant (edentulous section of a single tooth with the presence of adjacent teeth on both sides of the absence is accepted).
- •No sites with attachment loss (AL) > 3 mm in the area to be treated (second sextant).
- •Present full mouth plaque index (Ainamo and Bay, 1975) <15%.
- •Have bleeding on probing (BoP; Ainamo & Bay 1975) <15%.
排除标准
- •pregnancy or lactation
- •patients who smoke
- •patients under treatment with antimicrobials and anti-inflammatory drugs in the last 2 months or with medications associated with changes in the gingival tissue (antiepileptics, calcium channel blockers, etc.)
- •subjects with systemic conditions that alter the normal presentation of the gingival tissue (hereditary gingival fibromatosis) or those diagnosed with uncontrolled diabetes mellitus
- •patients with severe dental malposition and/or presence of dental implants in the area to be treated
- •use of orthodontic appliances
- •all those who present a disability or mental disorders that make it difficult for the patient to understand or follow them during the study period. study period.
结局指标
主要结局
The accuracy of surgical guide.
时间窗: 12 months
The accuracy of surgical guide to detect the cementoenamel junction and position of the alveolar bone crest: distance from the splint margin to the CEJ measured intra-surgically in mm at 3 points per tooth using a CP-15 periodontal probe (Hu Friedy®, Leimen, Germany).
次要结局
- The stability of the crown length(12 months)
- Patient's phenotype(12 months)
- The number of teeth and patients in which the second phase was necessary.(12 months)
- The time spent(12 months)
- Patient satisfaction(12 months)