跳至主要内容
临床试验/CTRI/2025/03/082985
CTRI/2025/03/082985尚未招募不适用

Evaluation Of The Effect Of Insulin like Growth Factor Application On Crestal Bone Level And Osseointegration Around Endosseous Implant.

Nextin Biocare Pvt Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
to evaluate implant stability around implants coated with insulin like growth factor

研究概览

简要总结

we will be evaluate the effect of IGF-1 gel coating on implant stability and crestal bone level on endosseous implants. this study is going to access the implant stability and crestal bone level around implants coated with and with out insulin like growth factor. Patients having edentulous sites and willing for implant placement will be selected from the Out Patient Department of Periodontology, Sibar Institute of Dental Sciences, Guntur, Andhra Pradesh, India. patients will be selected by the following criteria:   Individuals with an age group of 25-50 years of either gender,  Presence of adequate horizontal(4-5mm) and vertical (12mm) dimensions of the alveolar bone based on CBCT. ,Presence of adequate keratinized mucosa (minimum 1 mm) in the edentulous site., Apparently healthy individuals. Individuals with bone density classified as D2 and D3 type of bone. patients with any forms of tobacco users, Individuals with parafunctional habits, Pregnant and lactating women, Patients taking any medication which effect healing and bone metabolism, History of radiotherapy to head and neck. will bot be selected in the study. Total of 40 apparently healthy subjects will be selected into study. They will be randomly assigned into two groups consisting of 20 patients in each groupaccording to the inclusion and exclusion criteria.  Group 1(Control group): Implants without IGF-1 gel(n=20). Group 2(Test group): Implants coated with IGF-1 gel(n=20). IGF gel will be procured from Periobiologics LLP company in a 2cc syringe gel form. Implant size of 3.5mm width and 10mm in length will be used in the study. The study will be carried out for one and half year duration. And Patients with edentulous sites in the mandibular and maxillary arches with adequate alveolar ridge width and height will be considered into the study. Ridge characteristics will be measured clinically as well as radiographically with the help of CBCT. Sites fulfilling the study criteria will be included into the study**.** the following parameters will be evaluated at base line , 3 and 6 months, implants stability and radiographic bone level. methodology will be : Before surgery the patients will be advised to rinse with 5% povidone iodine mouthwash.,the procedure will be performed under local anaesthesia using 2% lignocaine containing adrenaline 1:80,000.  After adequate local anaesthesia with 2% lignocaine, a mid-crestal incision is given in both the cases.  A mucoperiosteal flap will be  elevated and osteotomy site will be prepared.  In Group 1(Control group) patients, implants will be placed without IGF-1 gel coating and in Group 2(Test group) implants will be coated with IGF-1gel. After placement, stability will be checked by RFA at baseline.  Cover screw will be given following the implant placement. Flaps will be approximated and sutured. Instructions regarding oral hygiene maintenance and soft diet plan will be provided. Patients will be discharged after prescribing analgesics and antibiotics.Patient will be recalled after 1 week for suture removal. crown placement will be done after 3 months.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Individuals with an age group of 25-50 years of either gender.
  • Presence of adequate horizontal(4-5mm) and vertical (12mm) dimensions of the alveolar bone based on CBCT.
  • Presence of adequate keratinized mucosa (minimum 1 mm) in the edentulous site.
  • Apparently healthy individuals.
  • Individuals with bone density classified as D2 and D3 type of bone.

排除标准

  • Any forms of tobacco users.
  • Individuals with parafunctional habits.
  • Pregnant and lactating women.
  • Patients taking any medication which effect healing and bone metabolism.
  • History of radiotherapy to head and neck.

结局指标

主要结局

to evaluate implant stability around implants coated with insulin like growth factor

时间窗: base line, 3 months and 6 months

次要结局

  • to evaluate the crestal bone level around implants coated with insulin like growth factor(baseline, 3 and 6 months)

研究者

发起方
Nextin Biocare Pvt Ltd
申办方类型
Other [implant manufacturer]
责任方
Principal Investigator
主要研究者

Lakshmi Kanth Kolaparthy

Sibar Institute of Dental Sciences

研究点 (1)

Loading locations...

相似试验