Evaluation of peri implant soft tissue and hard tissue in bone level and tissue level implants: A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Implant Stability(ISQ), Modified Sulcus Bleeding Index (Score 0-3), Peri-Implant Probing Depth, Marginal Bone Loss (mesial side and distal side), Keratinized tissue height and Gingival Biotype(Thin or Thick)
研究概览
简要总结
Background:
Osseo-integration is a prerequisite for long-term implant stability. Proper soft tissue seal to the titanium surfaces at the most coronal aspect of the implant body is required to prevent pathology that may interfere with osseo-integration process.
Conventional or bone level implants involve a two-stage surgery. Here, first the implant is placed at bone level after flap elevation and sutured for osseo-integration. In second stage, after 10-14 weeks, again a flap is raised to place the gingival former for another 3 weeks. Here the implant-abutment junction is in close proximity to the crestal bone.
It has been observed that the implant-abutment junction creates a micro-gap that creates path for the inflammatory infiltrate to cause marginal bone loss (die-back effect) and apical migration of junctional epithelium.
Better understanding of peri implant bone regeneration has led to more refined concepts of implant loading.
Tissue-level implants involve a single stage surgery where the tissue level abutment is placed along with the implant. It is attributed to creating a good mucosal seal of adequate width that mimics the biologic width. They have been attributed to eliminate the implant-abutment junction at the crestal bone level and shifts this junction at the tissue level, thus eliminating the micro-gap between these components. Prosthetic procedures don’t disturb the mucosal seal and protects it from contaminated oral surface.
In tissue level implants healing of bone and gingiva occurs simultaneously. It has been observed that this creates an early mucosal seal and disturb its seal during prosthetic steps.
The purpose of this study is to evaluate peri-implant soft-tissue and hard-tissue health conditions and changes seen in bone level and tissue level implants post prosthetic rehabilitation in these implants1. To assess the peri-implant soft tissue thickness in bone level and tissue level implants both pre-operatively and post-operatively.
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To assess the peri-implant soft changes seen in bone level and tissue level implants.
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To assess any crestal bone changes around the implant in bone level and tissue level implants.
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To evaluate the peri-implant soft-tissue and hard-tissue changes following prosthetic rehabilitation in bone level and tissue level implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group of 18 to 60 years
- •Patient Should be partially edentulous in posterior region of maxilla or mandible
- •Patients with good oral hygiene
- •ASA I and ASA II.
排除标准
- •ASA III and ASA IV, Pregnant or nursing women, Patients smoking more than 10 cigarettes a day, poor periodontal status, need for regenerative procedure and Intake of drugs that can interfere with bone healing and remodeling.
结局指标
主要结局
Implant Stability(ISQ), Modified Sulcus Bleeding Index (Score 0-3), Peri-Implant Probing Depth, Marginal Bone Loss (mesial side and distal side), Keratinized tissue height and Gingival Biotype(Thin or Thick)
时间窗: Implant Stability at 0, 3 and 6 months: | Modified Sulcus Bleeding Index 0, 3 and 6 months: | Peri-Implant Probing Depth 0, 3 and 6 months: | Marginal Bone Loss 0, 3 and 6 months: | Keratinized tissue height 3 and 6 months and Gingival Biotype
次要结局
- mplant Stability(ISQ), Modified Sulcus Bleeding Index (Score 0-3), Peri-Implant Probing Depth, Marginal Bone Loss (mesial side and distal side), Keratinized tissue height and Gingival Biotype(Thin or Thick)(Implant Stability at 0, 3 and 6 months:)
研究者
Amit Kashyap M R
Rajarajeshwari Dental college and hospital