A one-year Split-Mouth Randomized Controlled Trial to evaluate peri-implant mucosal health after cementation of Ultra-polished Zirconia crown compared with Conventionally polished Zirconia crown using periodontal indices (BOP, PD, PI) and Gingival biomarkers i.e. TNF-α and IL-1β
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- 1 To compare the gingival health between the study arms at time 1 month after cementation using Pocket Depth Plaque Index and using biomarkers TNF Aplha and IL 1 Beta
研究概览
简要总结
The roughness of the Crowns surface might affect the gingival health around Implant. Till Date conventionally polished Zirconia Crowns are used are prothesis over implants. Ultra polishing of Zirconia has been proposed to produce smoother surface. The aim of the Study is to evaluate and compare the effect of Conventionally polished and Ultra Polished Zirconia implant crowns on the gingival health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients requiring placement of implants for replacement of bilateral missing tooth site bound by natural teeth.
- •2.Adequate amount of available bone for placement of dental implant.
- •3.Well healed partially edentulous site 4.Good oral hygiene and periodontal status of remaining dentition.
- •5.Available for follow up.
- •6.With positive informed consent.
- •7.Both the edentulous areas having antagonist teeth.
排除标准
- •1 Bone metabolic disorders affecting surrounding bone health 2 Vertical soft tissue thickness of less than 2 mm in the implant site 3 History of radiotherapy in head and neck region 4 Current habit of smoking or alcohol or drug abuse 5 Systemic conditions and auto immune disorders that might affect the integrity of implant or connective tissue health surrounding the implant 6 Blood disorders such as Haemophilia sickle cell anaemia thrombocytopenia 7 Signs of infection in the prospective implant site or retained root 8 Pregnancy or lactating mothers at the time of enrolment 9 Parafunctional habits such as bruxism and clenching 10 Local limitations such as inadequate inter ridge distance or mesiodistal space.
结局指标
主要结局
1 To compare the gingival health between the study arms at time 1 month after cementation using Pocket Depth Plaque Index and using biomarkers TNF Aplha and IL 1 Beta
时间窗: Baseline 4 weeks 52 weeks
2.To compare the gingival health between the study arms at time 1 year after cementation using Pocket depth Plaque Index and using biomarkers TNF Aplha and IL 1 Beta
时间窗: Baseline 4 weeks 52 weeks
次要结局
- 1.To assess gingival health using BOP, PD, PI and using biomarker TNF- α and IL-1β just before cementation(T0), immediately1 month after cementation(T1) and at 1 year after cementation (T2) in the intervention arm of Ultra polished Zirconia crown(2.To assess gingival health using BOP, PD, PI and using biomarker TNF- α and IL-1β just before cementation(T0), immediately1 month after cementation(T1) and at 1 year after cementation (T2) in the control arm of conventionally polished Zirconia crown)
研究者
Dr Vaibhav Shegaonkar
CDER, AIIMS, New Delhi