Evaluation of gingival health and marginal bone levels in platform switching and platform matching implant abutment connections with different interocclusal space- A Randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 2. Periodontal Pocket depth
研究概览
简要总结
The success of implants relies heavily on the design of the implant-abutment interface, which affects load distribution, bacterial seal, soft tissue health, and emergence profile. Two main implant-abutment design includes platform switching and platform matching. Also flared abutments mimic natural tooth contours better than straight ones. Interocclusal height also influences gingival health and restoration outcomes. While previous studies have explored the effects of platform switching and platform matching on bone preservation and soft tissue health, the specific impact of these configurations on the emergence profile, especially in the molar region when combined with varying interocclusal heights, remains inadequately studied. Therefore, the study is a randomised controlled trial to evaluate the gingival health and marginal bone levels between 3 groups of implant abutment platforms – platform matching with straight abutment interface, platform matching with flared abutment interface and platform switching with conical connection with various interocclusal heights in a total of 72 patients with missing teeth in the molar region. The primary outcome variable is to evaluate the gingival parameters (bleeding on probing, peri implant probing depth and plaque index in the groups. The secondary outcome variable is to evaluate the radiographic marginal bone levels in implants in the following groups. The outcomes will be measured after final prosthesis delivery, 3 months and 6 months after insertion
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with missing single or two molar teeth in the maxillary and mandibular region.
- •Systemically healthy participants without any history of periodontal disease and smoking.
- •Patients having stable occlusion.
- •Edentulous region should be well rounded with adequate keratinised mucosa.
- •Patients with good oral hygiene.
- •Edentulous site with non tilted adjacent teeth.
排除标准
- •Patients developing systemic disease like diabetes mellitus etc, during the course of the study.
- •Participants who are pregnant or becoming pregnant during the course of the study.
- •Patients failing to obtain osseointegration after implant placement.
结局指标
主要结局
2. Periodontal Pocket depth
时间窗: One week after final prosthesis delivery, and follow up at three and Six months
3. Plaque index.
时间窗: One week after final prosthesis delivery, and follow up at three and Six months
Evaluation of Gingival Health:
时间窗: One week after final prosthesis delivery, and follow up at three and Six months
1. Bleeding on Probing
时间窗: One week after final prosthesis delivery, and follow up at three and Six months
次要结局
- Evaluation of radiographic marginal bone levels(After final prosthesis delivery, & follow up at three & six months)