Effect of Egg shell derived Nano-Hydroxyapatite (EnHA) in Direct Sinus Augmentation (DSA)- An Analytical Study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- CBCT scan will be used to determine density of bone and level of alveolar bone height, histomorphometric analysis will be used to evaluate presence of residual graft material and replacement of grafted material by host bone alongwith any resorptive or inflammatory changes.
研究概览
简要总结
Resorption of alveolar ridge and pneumatization of maxillary sinus makes the rehabilitation of posterior maxilla very challenging for which bone grafting is often required to make implant placement possible. The aim of this study is to evaluate the effectiveness of EnHA mixed with CGF in direct sinus augmentation procedure.
EnHA will be obtained from department of clinical research, Sibar institute of dental sciences, Guntur ap, in the biomedical material science laboratory, department of physics, Periyar university, Salem, Tamil Nadu, under department of science and technology, government of india funded project with grant no.- dst/tdt/wmt/agwaste/2021/01(g).
A pre-operative CBCT scan of maxillary arch will be made to see the available bone height in maxillary posterior region. Patients as per inclusion critera will be enrolled in the study after obtaining informed consent. Sinus lift procedure will be performed by lateral approach and EnHA with CGF will be grafted. Surgical wound will be sutured with 3-0 mersilk. Suture removal will be done on 10th postoperative day and patient would be followed up after 30 days, 90 days and 180 days.
CBCT scan will be made after 180 days to assess the bone quality. Dental implant of suitable dimension will be placed followed by placement of cover screw and subsequent prosthetic rehabilitation. 2mm trephine will be used to remove bone just prior to implant placement and will be sent for histomorphometric analysis.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Partially or completely edentulous posterior maxilla with residual height less than equal to 5mm.
- •6 months gap between tooth extraction and implant placement.
- •Presence of healthy or restored adjacent teeth.
- •Patients with ASA category I or II.
- •Excellent oral hygiene.
排除标准
- •Uncontrolled metabolic diseases, compromised immune system, haematological disorders, pregnancy, prior radiotherapy of maxillofacial region, chemotherapy, bone disease, medication or any other systemic illness which may affect prognosis of the treatment.
- •Radiographic evidence of maxillary sinus pathology.
- •History of sinusitis or maxillary sinus surgery.
- •Inadequate mouth opening.
- •Patients with habits of smoking, tobacco chewing, alcoholism, etc.
- •Patients not willing for egg shell derived graft material.
结局指标
主要结局
CBCT scan will be used to determine density of bone and level of alveolar bone height, histomorphometric analysis will be used to evaluate presence of residual graft material and replacement of grafted material by host bone alongwith any resorptive or inflammatory changes.
时间窗: 180 days
次要结局
- OPG will be taken to assess the stage of bone formation & clinical examination will be done to assess soft tissue healing(90 days)
研究者
Vikrant Dilip Sane
Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital Pune