The Influence of Soft Tissue Thickness On Crestal Bone Changes Around Submerged and Nonsubmerged Implants: A Randomized Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Crestal bone loss
研究概览
简要总结
Changes in the marginal bone level surrounding the implant are the frequently used parameters in assessing the short- and long-term success. Multiple biological and biomechanical factors have been reported to adversely affect marginal bone level. Recently, initial vertical mucosal tissue thickness has also been reported to have an impact on bone stability.The hypothesis of present study is that soft tissue thickness on implant placement has no positive impact of crestal bone remodeling.
详细描述
The aim of this study is to evaluate the clinical and radiographical results of submerged and nonsubmerged implants with thin (<3 mm) and thick (>3 mm) soft tissue over 1.5 year after implant placement. All submerged and nonsubmerged implants were randomly placed as split-mouth. Clinical periodontal parameters were recorded. Crestal bone levels were analyzed from the day of implants inserted to 1.5 year after prosthetic loading on digitally standardized radiographs. Non-parametric test were used for statistically analysis.
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
- Double (Participant, Investigator)
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
- •being older than 18 years of age
- •generally healthy patients, no medical contraindication for implant surgery
- •missing teeth in upper jaw posterior and more than one tooth in neighbourhood area
- •no bone augmentation procedures before and during implant placement.
排除标准
- •poor oral hygiene
- •history of periodontitis
- •alcoholism
- •taking medication which interferes soft and hard tissue healing
研究组 & 干预措施
Nonsubmerged thick group
Nonsubmerged type of implants placed with thick (>3 mm) soft tissue
干预措施: Implant (Other)
Nonsubmerged thin group
Nonsubmerged type of implants placed with thin (<3 mm) soft tissue
干预措施: Implant (Other)
Submerged thick group
Submerged type of implants placed with thick (>3 mm) soft tissue
干预措施: Implant (Other)
Submerged thin group
Submerged type of implants placed with thin (<3 mm) soft tissue
干预措施: Implant (Other)
结局指标
主要结局
Crestal bone loss
时间窗: Change from baseline crestal bone level at 18th month after placement,
Crestal bone loss was measured on radiographs between baseline-18th month after placement
Crestal bone loss
时间窗: Change from baseline crestal bone level at 4th month after placement,
Crestal bone loss was measured on radiographs between baseline-4th month after placement
Crestal bone loss
时间窗: Change from baseline crestal bone level at 6th month after placement,
Crestal bone loss was measured on radiographs between baseline-6th month after placement
Crestal bone loss
时间窗: Change from baseline crestal bone level at 12th month after placement,
Crestal bone loss was measured on radiographs between baseline-12th month after placement
次要结局
- Modified sulcus bleeding index(Modified sulcus bleeding index was recorded at 18th month after implant placement)
- Keratinized tissue level(Evaluation of keratinized tissue level at 18th month after placement (mm))
- Modified plaque index(Modified plaque index was recorded at 18th month after implant placement)
- Probing depth(Evaluation of probing depth at 18th month after placement (mm))
- Probing depth(Evaluation of probing depth at 4th month after placement (mm))
- Probing depth(Evaluation of probing depth at 6th month after placement (mm))
- Probing depth(Evaluation of probing depth at 12th month after placement (mm))
- Keratinized tissue level(Evaluation of keratinized tissue level at 4th month after placement (mm))
- Keratinized tissue level(Evaluation of keratinized tissue level at 6th month after placement (mm))
- Keratinized tissue level(Evaluation of keratinized tissue level at 12th month after placement (mm))
- Modified plaque index(Modified plaque index was recorded at 4th month after implant placement)
- Modified plaque index(Modified plaque index was recorded at 6th month after implant placement)
- Modified plaque index(Modified plaque index was recorded at 12th month after implant placement)
- Modified sulcus bleeding index(Modified sulcus bleeding index was recorded at 4th month after implant placement)
- Modified sulcus bleeding index(Modified sulcus bleeding index was recorded at 6th month after implant placement)
- Modified sulcus bleeding index(Modified sulcus bleeding index was recorded at 12th month after implant placement)