Development and Implication of Adhesive Scaffold for Regenerative and Mechanical Advances in Immediate Dental Implants
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine the effect of ABRS on the primary stability on the dental implants placed in fresh extraction sockets
研究概览
简要总结
Aim - To develop a bio-adhesive bone regenerative scaffold (ABRS) and to asses its clinical efficacy on soft tissue and bone regeneration around the immediate dental implant through a randomized controlled trial
Material and methodology - ABRS will be developed and characterized in CSIR-IITR Lucknow. 20 healthy adult patients requiring immediate implants will be randomly selected from the Department of Periodontology KGMU Lucknow. they will be allocated to group 1(Test-ABRS) and group 2(control- DFDBA) according to the table of random numbers. standard SLA treated root form dental implants 3.5-5mm wide and 8-12mm long dual thread internal hex design will be placed surgically after extraction in both groups. In group 1 ABRS will be injected in the prepared socket before the implant placement while in group 2 DFDBA will be placed around the implant by graft carrier. implants with a minimal insertion torque of 30Ncm will be loaded immediately. all the clinical and radiographic parameters will be measured at predetermined time points to assess soft tissue and hard tissue regeneration. bone healing will also be assessed through biomarker evaluation by multiplexing in initial 14 days. functional efficacy of the implant prosthesis will be measured subjectively through a PROM questionnaire. all these when statistically analyzed among the two groups will suggest the clinical efficacy of ABRS.
results - it is assumed that ABRS will enhance the primary and secondary stability of immediately placed dental implants more than the bone graft aiding in immediate functional prosthesis. the superior density of bone and faster bone healing are expected around dental implants in the ABRS group. due to the adhesive nature of the material suture less soft tissue healing is expected to result in a better soft tissue profile. superior functionality of the prosthesis is also anticipated. with this clinical trial, we will be able to provide immediate functional prosthesis to the otherwise contraindicated cases thus improving the quality of life of a major edentulous population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult patients 18 to 60 years both male and female having one or more teeth indicated for extraction are included they must be Negative for allergic testing for ABRS and ready to give written informed consent The jumping gap should be at least 2mm with all 4 cortical plate walls intact around the socket and have D1 D2 or D3 bone type.
排除标准
- •subjects with history of Smoking alcohol tobacco chewing drugs systemic conditions requiring medication pregnancy lactation history of allergic predisposition are excluded there should not be any acute periapical abcess or cysts existing ridge defect missing one or more cortical bone at the concerned site also mandibular anterior region and D4 bone are excluded.
结局指标
主要结局
To determine the effect of ABRS on the primary stability on the dental implants placed in fresh extraction sockets
时间窗: Primary stability will be measured by Radio Frequency Analyzer RFA and insertion torque at baseline 0 | The crestal bone level will be measured radiographically at 0 3 6 and 12 months and clinically by probing pocket depth assessment at 0 3 6 and 12 months | For bone healing Periâ€implant crevicular fluid samples will be obtained at 3 7 & 14 days after implant placement for Multiplexing | Quality of bone formed is assessed by DEXA scan at 0 3 6 and 12 months
To assess the effect of ABRS on crestal bone healing and regeneration
时间窗: Primary stability will be measured by Radio Frequency Analyzer RFA and insertion torque at baseline 0 | The crestal bone level will be measured radiographically at 0 3 6 and 12 months and clinically by probing pocket depth assessment at 0 3 6 and 12 months | For bone healing Periâ€implant crevicular fluid samples will be obtained at 3 7 & 14 days after implant placement for Multiplexing | Quality of bone formed is assessed by DEXA scan at 0 3 6 and 12 months
To determine the quality and quantity of bone formed around the dental implants
时间窗: Primary stability will be measured by Radio Frequency Analyzer RFA and insertion torque at baseline 0 | The crestal bone level will be measured radiographically at 0 3 6 and 12 months and clinically by probing pocket depth assessment at 0 3 6 and 12 months | For bone healing Periâ€implant crevicular fluid samples will be obtained at 3 7 & 14 days after implant placement for Multiplexing | Quality of bone formed is assessed by DEXA scan at 0 3 6 and 12 months
To conduct a comparative evaluation of all the above parameters with the market control
时间窗: Primary stability will be measured by Radio Frequency Analyzer RFA and insertion torque at baseline 0 | The crestal bone level will be measured radiographically at 0 3 6 and 12 months and clinically by probing pocket depth assessment at 0 3 6 and 12 months | For bone healing Periâ€implant crevicular fluid samples will be obtained at 3 7 & 14 days after implant placement for Multiplexing | Quality of bone formed is assessed by DEXA scan at 0 3 6 and 12 months
次要结局
- to assess the effect of ABRS on secondary stability on functional loads. to assess the effect of ABRS on the maintenance and healing of soft tissue profiles around dental implant crowns. To assess the functional ability of the implant prosthesis.(secondary stability will be measured by a radio frequency analyzer RFA at 3,6 and 12 months.)
研究者
Rameshwari Singhal
King Georges Medical University