Comparative evaluation of immediate implant placement & provisionalization with and without CGF-enriched bone graftA Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- hard and soft tissue changes clinically at baseline 3 & 6 months and radiographically using CBCT at baseline & 6 months post operatively
研究概览
简要总结
This is a Randomized Controlled clinical and radiographic trial designedto evaluate and compare the effect of immediate implant placement with provisionalization with and without CGF enrichedbone graft on hard and soft tissues in the peri implant area
Total 30 sites fulfilling the inclusion criteria inmaxillary anterior aesthetic area visiting the department of Periodontics andImplant Dentistry at VSPM Dental College and Research Centre Nagpur will beincluded in the study
Immediate implants with provisionalization will beplaced
The study population will be divided into 2 groups
GROUPI Immediate implant placement withprovisionalization without CGF enriched bone graft
GROUPII Immediate implant placement withprovisionalization with CGF enriched bone graft
The primary outcome will be assessment of hard &soft tissue changes after immediate implant placementclinically at baseline 3 and 6 months and radiographically using CBCT atbaseline and 6 months
The secondary outcome will be soft tissue assessment withTestori implant esthetic score
Bleeding on probing
Probing depth
Patientsatisfaction using VAS scale
The briefdescription of entire procedure will be given to every patient before startingthe procedure
Writteninformed consent will be obtained from the patients
Clinicalparameters
1 Mombelli’s modified Plaque index (mPI)
2 Mombelli’s modified sulcular bleeding index (mSBI)
3 Probing pocket depth (PPD)
4 Soft Tissue Assessment
5 Ridge Width Measurement
RadiographicParameters
1 Crestal bone height
2 Buccal bone thickness
3 Ridge width
4 Vertical Distance
5 Jumping Gap
6 Measuring the radiolucent area between shoulder of implant andbone crest
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA 1 Systemically healthy patients 2 Patient with healthy and stable soft tissue architecture 3 Sites at which minimum torque of 35 Ncm is obtained at the time of implant insertion 4 Co-operative motivated and hygiene conscious patients 5 Tooth/teeth with Grade I or II mobility required to be extracted 6 Root stumps 7 Tooth with endodontic failure or non-restorable caries or vertical fracture.
排除标准
- •EXCLUSION CRITERIA 1 General contraindications to implant surgery 2 Patients with a history of irradiation in the head and neck area within the last 6 months 3 Treated or under treatment with intravenous amino-bisphosphonates 4 Smokers or patients with poor oral hygiene 5 Patients with para-functional habits 6 Pregnant or lactating females.
结局指标
主要结局
hard and soft tissue changes clinically at baseline 3 & 6 months and radiographically using CBCT at baseline & 6 months post operatively
时间窗: baseline 3 and 6 months
次要结局
- Soft tissue assessment with Testori Implant Esthetic Score(Bleeding on probing)