Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile in Esthetic Zone and Patient Satisfaction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- pink esthetic score
研究概览
简要总结
This randomized controlled clinical study will be carried out to compare the digital with conventional impression procedures for the restoration of single implants in an esthetic zone by assessing:
- pink esthetic score (PES) of peri-implant soft tissue profile and marginal bone loss (MBL) as primary objectives
- Patients' satisfaction and clinical outcomes as secondary objectives
详细描述
fourteen patients with single nonrestorable tooth in the esthetic zone participated in the study and were replaced with immediate implants with immediate customized provisional restoration after 3 months they recalled for the impression, seven with digital and the others with conventional and evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders within age range of 20-50 years.
- •Systemically healthy participants classified as American Society of Anesthesiologists( ASA ) class I . Guided by medical questionnaire modified from Burkett's
- •Single non restorable tooth in upper anterior esthetic zone with at least 4 mm bone present apical to the root apex for primary stability.
- •Type I extraction sockets according to classification.
- •Ability to attend the surgery , comply to it's procedures , the recall visits and oral hygiene protocol .
- •Thick gingival phenotype with thickness ≥ 2 mm around the non-restorable tooth -
排除标准
- •Missing adjacent teeth or opposing tooth. .
- •Acute periapical pathosis or active periodontal infections related to non-restorable tooth or adjacent teeth.
- •Pregnant or lactating females.
- •Patients with para-functional habits (bruxism and/or clenching)
- •Vulnerable groups (handicapped, orphans, and prisoners). -
研究组 & 干预措施
Digital impression with intraoral scanner
included seven participants with non-restorable tooth in esthetic zone replaced by immediate implants receiving a single all ceramic crown fabricated with full digital procedure consisting of digital impression with intraoral scanner, and Computer Aided Design/ Computer Aided Manufacture (CAD/CAM) procedure.
干预措施: Intra oral scanner (Device)
conventional impression technique
included seven participants with non-restorable tooth in esthetic zone replaced by immediate implants receiving a single all ceramic crown fabricated with Conventional impression-taking with polyvinyl siloxane, plaster model pouring and lost-wax casting technique
干预措施: impression analog (Device)
结局指标
主要结局
pink esthetic score
时间窗: at the baseline(time of impression), second time was one week later (immediately) after crown placement, third time was one month later after crown placement , fourth time was three months later after crown placement
The pink esthetic score is based on seven variables: * Mesial papilla * Distal papilla * Soft-tissue level * Soft- tissue contour * Alveolar process deficiency * Soft-tissue color and texture Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score
marginal bone loss
时间窗: immediately after crown placement (baseline), then three months after crown placement
described by millimeter using paralleling technique
次要结局
- patient satisfaction(after crown placement)
- plaque index(Immediately after crown placement (baseline), one months later , and finally three months after crown placement)
- gingival index(Immediately after crown placement (baseline), one months later , and finally three months after crown placement)