The Effect of Platform Switching on Single Implants in the Esthetic Zone, Following Flapless Surgery and Early-Loading Protocols
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- plaque index
研究概览
简要总结
The impact of platform switching with flapless surgery on early-loaded single-tooth implants on esthetic outcomes.
详细描述
Evaluation of clinical, radiographic and microbial outcomes of single implants with platform switching, compared to those with conventional platform.
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 should be at least 18 years old and not currently pregnant
- •Systemically healthy with no medical contraindications to implant surgery
- •Having intact opposite tooth to proposed implant sites
- •The edentulous ridge with minimal ridge deformities.
排除标准
- •unstable medical status or conditions which may compromise wound healing
- •osseous metabolic disorders (e.g., osteoporosis, Paget's disease etc.)
- •uncontrolled dental or periodontal diseases
- •edentulous ridges with the presence of fibrous dysplasia, severe tissue undercut, residual root, as well as insufficient dimensions or volume
研究组 & 干预措施
platform-switched implants
platform-switched implants vs. platform-matched implants
干预措施: platform-matched implant (Other)
platform-matched implants
platform-switched implants vs. platform-matched implants
干预措施: platform-switched implants (Other)
结局指标
主要结局
plaque index
时间窗: post-loading 12 months
(Silness and Loe 1964). 0 represented the absence of plaque. 1 was the presence of plaque at gingival margin. 2 was the presence of visible plaque; whereas 3 was recorded if abundant plaque was observed
gingival index
时间窗: post-loading 12 months
As for GI, normal gingival was scored as 0. 1 meant the presence of mild inflammation, slight change in color, slight edema and no BOP. Moderate inflammation was represented by 2, inclusive of the presence of gingival redness, edema, glazing and BOP. Severe inflammation with marked redness, edema, ulceration and spontaneous bleeding was scaled as 3
Papillary index
时间窗: post-loading 12 months
(Jemt 1997) 0 = the absence of papilla, 1= \<50% of the height of the gingival embrasure, 2= 50-99% of the height of the gingival embrasure, 3 = 100% of the proximal space, 4= overgrowth of the interproximal tissue
The width of keratinized mucosa
时间窗: post-loading 12 months
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
Soft tissue level
时间窗: post-loading 12 months
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Probing depth
时间窗: post-loading 12 months
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
marginal bone level changes
时间窗: post-operative 2 weeks, immediately after crown delivery, 3, 6, and 12 months post-loading
the vertical distance between alveolar crest to platform level (both mesial and distal)
ridge height
时间窗: post-loading 12 months
the distance from the highest point of alveolar crest to the base of the maxillary arch
ridge width 3mm below crest
时间窗: post-loading 12 months
the distance between the most prominent point on labial and palatal surfaces at the level of 3mm below the crest
ridge width 10 mm below crest
时间窗: post-loading 12 months
the distance between the most prominent point on labial and palatal surfaces at the level of 10 mm below the crest
the presence of perforation or dehiscence
时间窗: post-loading 1 year
using CBCT scan
plaque index
时间窗: crown placement
(Silness and Loe 1964). 0 represented the absence of plaque. 1 was the presence of plaque at gingival margin. 2 was the presence of visible plaque; whereas 3 was recorded if abundant plaque was observed
plaque index
时间窗: post-loading 3 months
(Silness and Loe 1964). 0 represented the absence of plaque. 1 was the presence of plaque at gingival margin. 2 was the presence of visible plaque; whereas 3 was recorded if abundant plaque was observed
plaque index
时间窗: post-loading 6 months
(Silness and Loe 1964). 0 represented the absence of plaque. 1 was the presence of plaque at gingival margin. 2 was the presence of visible plaque; whereas 3 was recorded if abundant plaque was observed
gingival index
时间窗: crown placement
(Loe 1967) As for GI, normal gingival was scored as 0. 1 meant the presence of mild inflammation, slight change in color, slight edema and no BOP. Moderate inflammation was represented by 2, inclusive of the presence of gingival redness, edema, glazing and BOP. Severe inflammation with marked redness, edema, ulceration and spontaneous bleeding was scaled as 3
gingival index
时间窗: post-loading 3 months
As for GI, normal gingival was scored as 0. 1 meant the presence of mild inflammation, slight change in color, slight edema and no BOP. Moderate inflammation was represented by 2, inclusive of the presence of gingival redness, edema, glazing and BOP. Severe inflammation with marked redness, edema, ulceration and spontaneous bleeding was scaled as 3
gingival index
时间窗: post-loading 6 months
As for GI, normal gingival was scored as 0. 1 meant the presence of mild inflammation, slight change in color, slight edema and no BOP. Moderate inflammation was represented by 2, inclusive of the presence of gingival redness, edema, glazing and BOP. Severe inflammation with marked redness, edema, ulceration and spontaneous bleeding was scaled as 3
Papillary index
时间窗: crown placement
(Jemt 1997) 0 = the absence of papilla, 1= \<50% of the height of the gingival embrasure, 2= 50-99% of the height of the gingival embrasure, 3 = 100% of the proximal space, 4= overgrowth of the interproximal tissue
Papillary index
时间窗: post-loading 3 months
(Jemt 1997) 0 = the absence of papilla, 1= \<50% of the height of the gingival embrasure, 2= 50-99% of the height of the gingival embrasure, 3 = 100% of the proximal space, 4= overgrowth of the interproximal tissue
Papillary index
时间窗: post-loading 6 months
(Jemt 1997) 0 = the absence of papilla, 1= \<50% of the height of the gingival embrasure, 2= 50-99% of the height of the gingival embrasure, 3 = 100% of the proximal space, 4= overgrowth of the interproximal tissue
The width of keratinized mucosa
时间窗: crown placement
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
The width of keratinized mucosa
时间窗: post-loading 3 months
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
The width of keratinized mucosa
时间窗: post-loading 6 months
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
Soft tissue level
时间窗: crown placement
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Soft tissue level
时间窗: post-loading 3 months
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Soft tissue level
时间窗: post-loading 6 months
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Probing depth
时间窗: crown placement
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
Probing depth
时间窗: post-loading 3 months
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
Probing depth
时间窗: post-loading 6 months
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
ridge height
时间窗: prior to surgery
the distance from the highest point of alveolar crest to the base of the maxillary arch
ridge width 3mm below crest
时间窗: prior to surgery
the distance between the most prominent point on labial and palatal surfaces at the level of 3mm below the crest
ridge width 10 mm below crest
时间窗: prior to surgery
the distance between the most prominent point on labial and palatal surfaces at the level of 10 mm below the crest
次要结局
- post-op experience(post-op 2weeks)
- microbial analysis(12 months after loading)
- post-loading experience(post-op 12 months)
研究者
Yung-Ting Hsu
resident, Graduate Periodontics
University of Michigan