跳至主要内容
临床试验/CTRI/2024/05/067904
CTRI/2024/05/067904进行中(未招募)Phase 3 4

Immediate Implants in extraction sockets with periapical lesions: A Prospective study

ITS Centre for Dental Studies and Research1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年6月24日最近更新:

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 incon­clusive and unclear as to whether immediate implant placement into sites with periapical infec­tion 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

发起方
ITS Centre for Dental Studies and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Jason Nongmaithem

ITS CDSR Ghaziabad

研究点 (1)

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