Comparative evaluation of Peri-implant marginal tissues in soft tissue-level versus bone level implants – a randomized split-mouth clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Marginal bone loss around soft tissue level and bone level implants
研究概览
简要总结
Research Question - Does the choice of Soft tissue level (STL) or Bone Level (BL) implant impact per implant tissues when patient related, surgery related, and prosthesis related variability is controlled?
Null hypotheses
1 There is no difference in the Means of clinical, microbial, biomarker and metabolomic measures from peri implant tissues around soft tissue level and bone level implants
2 There is no correlation between clinical indices, microbiota, biomarkers and metabolites and soft tissue level or bone level implants
Aims
1 To conduct prospective split mouth trial to compare soft tissue level and bone level implants
2 to perform comprehensive clinical, microbial, biochemical and metabolomic evaluation
Trial design
Prospective split mouth randomized controlled clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients requiring implant insertion in premolar-molar region of right & left side of jaw located contiguous to natural teeth, tooth-bound edentulous space Healed implant sites with adequate osseous architecture, thick gingival biotype Absence of antibiotic therapy in the previous three months Nondiabetic (HbA1c less than 6.0 percent), Vit D more than 20ng per ml Signed informed consent and willing to come for follow up.
排除标准
- •Absence of keratinized tissue or need for crestal bone augmentation of implant site Diagnosis or History of periodontitis Systemic conditions contraindicating surgery, infectious diseases, medications influencing bone metabolism, immune modulators, previous pathologic conditions, bruxism, SSRI Pregnancy and lactation Smoking.
结局指标
主要结局
Marginal bone loss around soft tissue level and bone level implants
时间窗: 6,12,18 months
次要结局
- Probing depth, Plaque Index and Bleeding on probing around soft tissue level and bone level implants(6,12,18 months)
- Submucosal microbiota using real time PCR around soft tissue level and bone level implants(6,18 months)
- Matrix metalloproteinase (MMP) in peri implant crevicular fluid around soft tissue level and bone level implants(6, 18 months)
- Comparative metabolomics of peri implant crevicular fluid around soft tissue level and bone level implants(6,18 months)
研究者
Arvind R
Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education, Manipal