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临床试验/CTRI/2024/07/071152
CTRI/2024/07/071152尚未招募3 期

Assessment of effectiveness of socket shielding in the placement of immediate implants in anterior aesthetic region

Ashwin Shravan Kumar1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年8月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Replacement of graft

研究概览

简要总结

Aims and objectives: The aim of the study is to provide an alternative treatment modality in immediate implant placement in the anterior aesthetic region by assessing the effectiveness of socket shielding technique for immediate implant placement with respect to specific clinical and radiographic parameters.

The main objectives of study will be:

  1. Reducing need of bone graft there by reducing the cost of treatment
  2. Reducing the post operative complications of grafting
  3. Making a convenient and easy surgical technique thereby reducing operating time
  4. Promoting faster osseointegration of implants
  5. Providing a minimally invasive procedure benefitting the general population
  6. Providing more aesthetic value to the therapy

Materials and methods:

Type Of Study : prospective study

Site of study : Sree Balaji Dental College and Hospital

Samplesize : 10

Sampling method: Purposive sampling

Study Design : clinical study

Funding : self

Expenditure : 90000

INITIALLY THE STUDY WILL BE PERFOMED BY SKILLED PROFESSIONAL AND THE INVESTIGATOR WILL BE PERFORMING UNDER GUIDANCE AFTER PROPER OBSERVATION OF INITIAL CASES

Inclusion criteria:

Cases requiring extraction of teeth in the anterior region of maxilla and mandible

Patients above 18 years of age

Exclusion criteria:

Anterior teeth requiring extraction with periapical pathology.

Completely edentulous patients.

Immunocompromised patients.

Patients with other systemic conditions contraindicated for surgery.

Procedure:

  1. Patient consent both written and informed will be obtained

  2. Pre-operative assessment and examination

2a. History of the patient: The pre-operative data will be collected and recorded including name, age, gender, occupation, address, onset and aetiology of the fracture

2b. Clinical examination

Extraoral examination

Inspection: To record swelling, or sinus discharge in the teeth to be extracted.

Intraoral examination

Inspection: To find out mobility, presence of any cystic lesion or sinus tract opening

Palpation: To detect areas of tenderness and alteration of bony contour, each tooth was examined for mobility and fracture.

2c. Radiographic examination:

Standard orthopantomograms (OPG) and intraoral periapaical radiographs (IOPA)  will be performed for all the cases.

  1. Operative Procedure

Patient will be prepared under sterile aseptic protocol

Preparation of surgical site will be done with 5% betadiene solution

Local anaesthesia (lignocaine) with adrenaline (1:80000) will be administered in buccal and palatal aspects as infiltration anaesthesia

Vertical release incision will be placed

Full thickness mucoperiosteal flap will be raised

Tooth will be sectioned using periotome and palatal fragment will be removed leaving behind the intact buccal fragment

Pulp tissue if present will be extripated

Initial pilot drill will be placed followed by sequential drilling

Implant will be placed in the socket and cover screw placement to be done

Check Xray will be taken for analysing the position of implant

Closure of socket will be done using simple interrupted or mattress suture

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

  • patients requiring extraction of anterior teeth due to trauma.

排除标准

  • patients requiring extraction of anterior teeth due to periodontitis patients requiring extraction of anterior teeth due to periapical pathologies medically compromised patients.

结局指标

主要结局

Replacement of graft

时间窗: At baseline, 1 week, 4 week and 12 week

Better stability of implant

时间窗: At baseline, 1 week, 4 week and 12 week

次要结局

  • Bone growth & bone loss(Osse integration of implant)

研究者

发起方
Ashwin Shravan Kumar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ashwin Shravan Kumar

Sree Balaji dental college and hospital

研究点 (1)

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