跳至主要内容
临床试验/CTRI/2023/10/058921
CTRI/2023/10/058921尚未招募不适用

A comparative evaluation of Flapless versus Open Flap technique for Implant placement

Sardar Patel Post Graduate Institute of Dental and Medical Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年10月19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
20
试验地点
1
主要终点
The possible outcome of this study will be to see the lesser reduction in crestal bone height, better peri-implant health and would healing using flapless technique than open flap technique for implant placement

研究概览

简要总结

The present above mentioned Thesis " A comparative evaluation of flapless vs open flap technique for implant placement " is to evaluate and comparethe effect of flapless and “open flap†technique of implant placement oncrestal bone height around implants. It is going to be held over a period of 2 years. The study shall be carriedout on patients having bilateral missing mandibular molars in the out-patients department of Oral and Maxillofacial surgery in Sardar PostGraduate Institute of Dental and Medical Sciences. Patient will be selected according to inclusion criteria and asample size of 20 patients which includes patients those having bilateralmissing molar and will be randomly allocated to Group A and Group B. In Group Aimplant will be placed using flapless technique and in Group B by using openflap technique.

In case of “flapless†technique, with the use of tissue punchguide according to implant size, soft tissue is punched out with the tissuepunch followed by osteotomy using a pilot drill of 2mm through surgicaltemplate. Subsequent drilling will be done to prepare the site according to theselected implant size. After the complete embedding of the endo-osseous rootform implant into the bone, secondary healing cap will be tightened over theimplant to allow tissue healing. Another implant will be placed on the oppositeedentulous site using “open flap†technique by reflecting mucoperiosteal flap.IOPA radiograph will be taken after the procedure to confirm complete insertionof the implant. Postoperative antibiotics and analgesics will be prescribed tothe patient for 5 days. Patient will be followed up for 6 months after implantplacement and assessed for post operative pain, wound healing, peri-implantitis,papillary index and crestal bone height. The crestal bone height will bemeasured using IOPA. All the participants involved in this study will beadvised for IOPA at the time of placement and post operatively 6 months afterthe implant placement.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA Grade I,II patients 2.Patient with bilateral missing mandibular molars.
  • 3.Patient age between 18-40 years 4,Good oral hygiene 5.Adequate bone volume for implant placement.

排除标准

  • Patient with complicated medical history such as uncontrolled diabetes, bleeding disorders, osteoporosis; patients on radiation therapy; and immunocompromised states.
  • Untreated periodontitis
  • Smokers •Patients with parafunctional habits.

结局指标

主要结局

The possible outcome of this study will be to see the lesser reduction in crestal bone height, better peri-implant health and would healing using flapless technique than open flap technique for implant placement

时间窗: At baseline,1st day, 3rd day, 5th day, 7th day, 4 months and 6 months

次要结局

  • Successful dental implant surgery providing patients with teeth in missing dental segments with; decreased surgical time; improved patient comfort; & accelerated recuperation, allowing the patient to resume normal oral hygiene procedures immediately after the procedure(at baseline, 1st day, 3rd day, 5th day, 7th day, 4 months & 6 months)

研究者

发起方
Sardar Patel Post Graduate Institute of Dental and Medical Sciences
申办方类型
Research institution

研究点 (1)

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