Immediate Implants in extraction sockets with periapical lesions: A Prospective study
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1.RFA to check the implant bone stability at baseline and at 4months of follow up
研究概览
简要总结
Immediate implant placement of dental implants into fresh extraction sockets was shown to be a predictable and successful procedure when proper protocols were followed. Immediate implant placement into infected sockets has resulted in variable success rates. To date results from published studies are inconÂclusive and unclear as to whether immediate implant placement into sites with periapical infecÂtion increases the risk of implant failure or successful osseointegration. This study aims to evaluate the efficacy of immediate implants placement in fresh extracted sockets with peri-apical lesions as compared to without peri-apical lesions. This Prospective controlled trial will consist of a Control Group with patients with 12 extraction socket without peri-apical infection and study Group of patients with 12 extraction sockets with peri-apical infection. All patients will follow a pre-operative regimen of 0.12% chlorhexidine mouthwashes and 625 mg amoxicillin/clavulanic acid. In the study group after traumatically extracting the tooth with peri-apical pathology, the alveolae will undergo meticulous curettage in all socket walls to remove all the granulation tissue and will be disinfected. Osteotomy will be prepared on the palatal side by sequential drilling protocol according to the implant size indicated by the implant manufacturer, by Adin. After sequential drilling, the implant placement will be done achieving insertion torque
35 N/ cm in all cases and cover screw will be placed. All cases will be followed up after 1 week and at 4 months. At week 1 of follow up VAS score will be used to assess for pain. Implant survival, Implant Stability Quotient (ISQ) by RFA and Labial bone thickness at the baseline and at 4 months of follow up will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Age 18-65 years of both gender 2.Immediate implants in the aesthetic zones only 3.ASA1 and 2 4.Buccal bone should be upto or greater than midroot level of the tooth.
- •5.Adequate bone at least 2-3 mm beyond the apex of the tooth or beyond the peri-apical lesion 6.In case of larger peri-apical lesions needing apical buccal access for curettage, adequate 3 dimensional bone should be present cervically.
排除标准
- •1.Medically compromised patients.
- •2.Presence of acute peri-apical pathology 3.Smoking and tobacco users 4.Patient undergoing chemotherapy and radio therapy 5.Pregnant and lactating patients 6.ASA 3 and 4 7.Bone less than 2 mm beyond the apex of the tooth or beyond the peri-apical area.
结局指标
主要结局
1.RFA to check the implant bone stability at baseline and at 4months of follow up
时间窗: 1.RFA to check the implant bone stability at baseline and at 4months of follow up | 2.CBCT at baseline and at 4 months of follow up to evaluate the thickness of the labial bone | 3. VAS score for presence of pain at week 1 of follow up
2.CBCT at baseline and at 4 months of follow up to evaluate the thickness of the labial bone
时间窗: 1.RFA to check the implant bone stability at baseline and at 4months of follow up | 2.CBCT at baseline and at 4 months of follow up to evaluate the thickness of the labial bone | 3. VAS score for presence of pain at week 1 of follow up
3. VAS score for presence of pain at week 1 of follow up
时间窗: 1.RFA to check the implant bone stability at baseline and at 4months of follow up | 2.CBCT at baseline and at 4 months of follow up to evaluate the thickness of the labial bone | 3. VAS score for presence of pain at week 1 of follow up
次要结局
- Hisptopathological findings of study group(VAS score for presence of pain at week 1 of follow up)
研究者
Jason Nongmaithem
ITS CDSR Ghaziabad
