Evaluation of Pink Esthetic Score and Soft Tissue Changes Following Immediate Implants Using Partially Demineralized Dentin Matrix as Jumping Gap Filling Material Versus Xenograft. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pink esthetic score
研究概览
简要总结
Will there be a difference in Pink Esthetic score and soft tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix compared with xenograft?
详细描述
This study aims to evaluate the soft tissue changes as well as hard tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix in comparison to xenograft.
Because xenogeneic bone is so readily available in substantial quantities, it has been the subject of notable research. However, because they contain organic material from a foreign species, xenogeneic bones are inherently very antigenic.
According to experimental results, PDDM encourages bone regeneration in a manner like autogenous bone. Both cortical bone and autogenous tooth grafts share similar physical and chemical characteristics, including optimal biodegradability, not requiring a separate surgery to harvest the graft and space maintenance capabilities. PDDM is a valuable comparator to autogenous bone in ARP and around dental implants in guided bone regeneration procedures
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 (Investigator, Outcomes Assessor)
盲法说明
The two groups will be equally prepared for both surgical procedures. Then the decision of which group will receive (PDDM), and which will receive xenograft will be taken according to the randomized numbers placed in opaque sealed envelopes. The number will be picked by the supervisor.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients above 18 years of age; with non-restorable teeth requiring replacement with immediate implants in the maxillary esthetic zone.
- •Absence of active infection at the surgical site.
- •Adequate primary stability following immediate implant placement.
- •Intact socket walls following the extraction.
- •Class I dental socket based on a preoperative CBCT scan
- •Buccal plate thickness more than 1 mm and thick biotype.
- •Compliant patients who will sign an informed consent and agree to the follow up period.
排除标准
- •Poor oral hygiene or the lack of regular maintenance.
- •Individuals with compromised immune system or debilitating systemic disease.
- •The presence of parafunctional habits (bruxism or clenching).
- •External root resorption.
研究组 & 干预措施
Partially demineralized dentin matrix graft
- A high-speed fine finishing stone and saline irrigation will be used to clean extracted teeth from periodontal ligaments, soft tissue attachments, caries, and restorations if present.
- Teeth particles will be partially demineralized using nitric acid 2% for fifteen minutes.
- Finally, the prepared partially demineralized dentin matrix graft granules will be washed twice with distilled water and phosphate buffered saline
- Immediate implant of appropriate dimensions will be placed and the previously prepared partially demineralized dentin matrix graft will be used to graft the jumping gap.
- Customized healing abutment will be used.
- In Osseo integrated implants temporary abutment will be removed and impressions for final restoration will be performed after 3 months.
干预措施: Immediate implant (Procedure)
xenograft
- After tooth extraction, thorough curettage will be performed.
- Immediate implant of appropriate dimensions will be placed, and the jumping gap will be grafted with xenograft "Cerabone" .
- Customized healing abutment will be used.
- In Osseo integrated implants temporary abutment will be removed and impressions for final restoration will be performed after 3 months.
干预措施: Immediate implant (Procedure)
结局指标
主要结局
Pink esthetic score
时间窗: twelve months after final restoration
a fourteen point scale to evaluate pink esthetics. The pink esthetic score (PES) estimates the esthetic results of soft tissue surrounding the implant with regarding 7 points : mesial, distal papilla, soft tissue margin, soft tissue contour, alveolar process, colour, texture. the score of zero will be lowest and two will be the highest for each of the seven points with zero being the lowest and 14 being the highest.
次要结局
- Patient satisfaction(one year after final restoration)
- Vertical and horizontal radiographic changes in bone dimensions(immediate post operative and twelve months after final restoration)
- Midfacial mucosal alteration(preoperative and twelve months after final restoration)
研究者
Mihad Ibrahim
Assistant lecturer
Cairo University