socket shield technique versus conventional immediate implant placement in anterior maxillary region-A randomised prospective comparative study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- primary outcome is to evaluate Mobility (Misch’s Clinical implant stability),Implant Primary and secondary stability (Osstell),Measurement of the amount of vertical and horizontal bone loss as seen on CBCT (Cone Beam Computed Tomography).
研究概览
简要总结
The study shall be carried out on patients attending the Out Patient Department (OPD) of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, with permission from Institutional Ethical Committee (IEC). A written informed consent will be obtained from each patient after explaining the nature and outcome of procedure and the possible consequences and complications. Patient will be selected irrespective of caste, creed, sex, religion or socio-economic status.Each patient will be randomly allocated to group I and group II using lottery method.All the cases will undergo thorough history taking and clinical examination. Radiographs will be taken (CBCT). Routine blood investigations and viral markers will be done.
Two groups will be made and patient will be randomly allocated to Group A (Socket shield technique) and Group B (conventional immediate implant placement).
Following consent the surgical field will be prepared and isolated and area will be anesthetized using 2% Xylocaine hydrochloride with epinephrine (1: 80,000). In Group A patients tooth extraction will be done by socket shield technique with the sequential use of burs. In the first step tooth crown will be sectioned at the cervical level followed by sectioning the tooth mesio-distally. This will split the roots labially and palatally followed by atraumatic removal of palatal portion of root. Thus the labial wall of root will be left intact and will be contoured in cresent shape. Now the site for implant placement will be prepared by sequential drilling, surrounded by tooth root on buccal side and bone on palatal side.
While in Group B patients tooth extraction will be done followed by immediate implant placement without leaving any portion of the tooth root in the extraction socket. Closure in both group A and group B patients will be done using 3-0 mersilk suture and patient will be evaluated for post operative pain and wound healing on 1st,3rd ,5th and 7th day ;for implant mobility, periimplantitis on 4th and 6th month, for implant stability at the time of implant placement and 6th month; for radiographic evaluation of buccal crestal bone height at pre-operative, immediate post operative ,4th month and 7th month.
Post operatively analgesics and antibiotics will be prescribed for 5 days. The patients will be advised to maintain proper oral hygiene.
Radiographs and photographs will be taken prior to extraction procedure and during follow ups at regular intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator 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
- •American Society of Anaesthesiologist Classification (ASA) I and II patient.
- •Patients under Sagital Root Position classification (SRP) class I and class II
- •Patients with fractured maxillary anteriors without fractured cortical plates or any associated pathology 3.Patients age between 18-40 years 4.Good oral hygiene 5.Adequate bone volume for implant placement.
排除标准
- 未提供
结局指标
主要结局
primary outcome is to evaluate Mobility (Misch’s Clinical implant stability),Implant Primary and secondary stability (Osstell),Measurement of the amount of vertical and horizontal bone loss as seen on CBCT (Cone Beam Computed Tomography).
时间窗: estimated time may range upto 7 months
次要结局
- secondary outcome is to evaluate pain,wound healing,paillary index and periimplantitis(estimated time may range upto 7months)