Comparative evaluation of peri-implant soft tissue response to graphene reinforced PMMA and PEEK customized healing abutments: A randomized clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
研究概览
简要总结
This randomized clinical trial aims to evaluate and compare the peri-implant soft tissue response to graphene-reinforced PMMA and PEEK customized healing abutments placed during second-stage implant surgery. A total of 22 patients undergoing implant therapy will be randomly allocated into two groups. Customized healing abutments will be digitally designed and fabricated using CAD/CAM technology. Peri-implant soft tissue parameters including bleeding on probing, plaque accumulation, probing depth, mucosal thickness, horizontal and vertical soft tissue dimensions, and patient-reported discomfort will be assessed at baseline and 3 weeks after placement. The study intends to generate clinical evidence regarding the soft tissue behavior of graphene-reinforced PMMA compared to PEEK to support material selection in implant prosthodontics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with the age 18 years and above.
- •Partially Edentulous cases indicated for implant iii.
- •Patient with informed consent willing to participate in the study.
排除标准
- •Patient not indicated for dental implant procedure like a.
- •Patients on anticoagulant, corticosteroid, fibrinolytic and anti-platelet therapy, b.
- •Patients with bleeding disorders c.
- •Patients with debilitating diseases.
- •Patients requiring immediate implant placement following tooth extraction iii.
- •Patients in whom an immediate transmucosal healing abutment was planned to be placed at the time of implant insertion iv.
- •Patients receiving medications that interfere with bone metabolism or soft tissue healing v.
- •Presence of active infection or acute inflammatory pathology at the proposed implant site.
- •Sites requiring extensive guided bone regeneration or major augmentation procedures at the time of implant placement.
- •Pregnant or lactating women, viii.
- •Patients with a history of smoking or tobacco use ix.
- •Patients unable or unwilling to comply with the study protocol, including scheduled follow-up visits, oral hygiene instructions, or postoperative care requirements.
研究者
Dr Damodar Shanbhag
Rural Dental College, Pravara Institute of Medical Sciences.