Effect of Abutment 3-dimensional Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- midfacial keratinized mucosa width
研究概览
简要总结
The aims of our study are to investigate in patients with immediate implantation replacing a single tooth in the maxillary anterior (#FDI 15-25) region the effect of (a) custom vs cylindrical stock healing abutments, then (b) screw retained single ceramic crowns, on the peri implant hard- and soft-tissue formation and blood flow.
详细描述
AIMS:
In the maxilla, in the aesthetic zone, in patients with a thick phenotype, for a crown anchored with a solo immediate implant:
I.A To investigate hard and soft tissue volume changes around custom CAD/CAM (computer-aided design and manufacturing) vs. cylindrical zirconiom-dioxide (ZrO2) healing abutments 4 months after their fixation for immediate implant placement.
I.B To measure the thickness of keratinized mucosa by ultrasound I.C Monitoring microcirculation in wound healing by laser speckle contrast imaging (LSCI) and ultrasound.
II. Custom zirconia abutment (on Ti-base) retained, screw-retained all-ceramic solo restorations:
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
- None
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
- •patients over 18 years
- •good general health
- •good oral hygiene (FMPS < 25%)
- •healthy periodontium (PPD < 4mm)
- •thick phenotype
- •maxilla anterior region (extended to 15-25 positions)
- •solo missing teeth, intact adjacent teeth
- •type 1 alveolar shape after extraction 1
- •retained occlusion
- •baseline buccal bone wall thickness at least 1.5 mm, based on intact CBCT scan
- •patient voluntarily accepts and signs the information and consent form for the study
排除标准
- •general ill health
- •general surgical or oral surgery contraindication
- •a patient who has undergone local radiotherapy
- •active periodontal inflammation, inflammation of the alveolar cavity
- •posterior region
- •pregnancy, lactation
- •psychological or mental involvement affecting individual plaque control
- •presence of an implant adjacent to the planned implant
- •inadequate oral hygiene
- •need for vertical bone augmentation
- •gingival recession
- •Inappropriate implant position for screw fixation
结局指标
主要结局
midfacial keratinized mucosa width
时间窗: 4, 12, 36 months post op.
Keratinized mucosa width \[mm\]
Keratinized mucosa thickness
时间窗: before implantation, 4,12, 36 months post op.
Keratinized mucosa thickness with ultrasound \[mm\]
midfacial keratinized mucosa volume
时间窗: 4, 12, 36 months post op.
Volume changes in midfacial mucosa \[mm\]
次要结局
- Probing depth (PPD)(0., 4., 12., 36. month after implantation)
- Pain at delivery(4 months after implantation, at final restoration delivery)
- ultrasound(at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation)
- marginal bone loss(4, 12, 36 months post op.)
- full mouth bleeding score (FMBS)(0. day, and 4., 12., 36. month after implantation)
- Functional implant prosthodontic score (FIPS)(4 months after implantation, at final restoration delivery)
- soft tissue volume(4, 12, 36 months post op.)
- laser speckle contrast imaging (LSCI)(at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation)
- full mouth plaque score (FMPS)(0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation)
- Implant survival(4, 12, 36 months)