Comparison of clinical outcomes, histomorphometric and gene expression analysis of connective tissue graft with two types of xenogeneic matrices for peri-implant vertical soft tissue augmentation
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 3. Gene expression profile of grafted tissue
概览
简要总结
Peri-implant soft tissues are key to maintaining peri-implant health. An adequate soft tissue seal prevents microbial ingress, provides aesthetic results and harmonious integration of the prosthesis with the remaining dentition. The connective tissue graft (CTG) harvested from the palate is the gold standard for soft tissue augmentation. However, it is associated with a need for a second surgical site, increased patient morbidity, longer surgical duration and a possibility of postsurgical complications. To address these challenges, several new biomaterials have been developed. These include newly developed porcine acellular dermal matrix (PADM) and volume stable collagen matrix (VCMX). However, it remains unclear whether they can achieve similar clinical outcomes as CTG in terms of vertical soft tissue thickness gain following submerged implant placement. The present study is aimed at comparing the clinical performance of PADM, VCMX and CTG for vertical soft tissue augmentation at implant sites presenting with baseline soft tissue thickness ≤ 2 mm. Further, histologic and histomorphometric assessment would be carried out to evaluate the inflammatory response, collagen content and micro-vessel density in the grafted tissue after 3 months of healing. Also, there is lack of data on the gene expression of biological importance during healing at molecular level in the grafted sites. Therefore, we will also characterize acute changes in gene expression by performing RNAseq analysis of the biopsied soft tissue to identify cellular pathways that become altered upon successful grafting in VCMX or PADM groups compared to CTG control.
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
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •(j) Systemically healthy individuals over 18 years of age (k) Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy.
- •(l) Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of less than 15 percent (m) Presence of single missing posterior tooth indicated for implant-supported prosthesis (n) Thin mucosal tissues , less than or equal 2 mm in vertical dimension i.e. covering the edentulous alveolar ridge (o) Minimum of 6 mm width and 8 mm height of available bone.
- •(p) Presence of minimum 4 mm of keratinized tissue buccolingually (q) No need of bone augmentation procedure before and during implant placement (r) Provide consent for the use of soft tissue matrix of porcine origin.
排除标准
- •(a) Insufficient inter-arch space for implant-supported crown (b) Inability or anticipated failure to maintain adequate oral hygiene (c) Pregnancy or lactating moth¬ers (d) Patients with other systemic conditions (uncontrolled diabetes, unstable bleeding disorders, active infectious diseases; hepatitis, tuberculosis, HIV etc.) that could affect the healing ability of wound.
- •(e) Mental disabilities that may hinder participation.
- •(f) History of active immunosuppressive therapy, cancer therapy and/or radiation to the oral cavity.
- •(g) Patients taking medications that affect the healing of soft tissues (e.g. NSAIDs, steroids, etc.).
- •(h) Smokers or tobacco usage in any form.
结局指标
主要结局
3. Gene expression profile of grafted tissue
时间窗: 3 months
1. Vertical soft tissue thickness gain
时间窗: 3 months
2. Histological assessment of grafted tissue
时间窗: 3 months
次要结局
- Duration of Surgery(Post-operative Pain)
研究者
Dr Vikender Singh
AIIMS, New Delhi