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临床试验/CTRI/2024/04/066238
CTRI/2024/04/066238尚未招募4 期

Comparative evaluation of clinical and radiographic outcomes of two commercially available implant systems for treating partially edentulous patients – a prospective study

未提供1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
20
试验地点
1
主要终点
evaluation of implant

研究概览

简要总结

Aim of the study is to  evaluate and compare the clinical and radiographic outcomes of two different implant systems Adin and Osstem in the treatment of partially edentulous arches. All the participants will be explained the need and design of the study. Informed and written consent will obtained from the patients. Thorough clinical case history will be recorded. A full mouth supragingival and subgingival scaling and root planing procedure will be performed. 2 weeks after phase I therapy, a clinical and radiographic evaluation will be performed to confirm the suitability of the sites for this study. The selected sites will be divided randomly into A and O groups. Group A will be treated with ADIN implants, whereas group O will be treated with OSSTEM implants. Clinical parameters like pain intensity from implant region using visual analogue scale (VAS), implant stability using the first generation Osstell instrument , modified plaque index (PI) , modified sulcus bleeding index,  probing pocket depth, width of masticatory mucosa (Wma) and radiographic assessment will be done.  Intraoral antisepsis will be performed with 0.2% chlorhexidine digluconate rinse and an iodine solution will be used to carry out extra oral antisepsis. After administration of local anesthesia, horizontal crestal incision following, mucoperiosteal flaps will be reflected. Care will be taken to preserve as much interproximal soft tissue as possible. Sequential osteotomy will be done and suitable size implant body will be placed with the help of a rachet. The implant body will be covered by cover screw. The mucoperiosteal flaps will be repositioned and secured in place using non-absorbable black silk surgical suture. The interrupted suture will be placed. Surgery will be performed at 2 stages in both site A and O : Stage 1 – implant body will be placed covered by cover screw. Stage 2 – cover screw will be removed and healing abutment will be placed (4 months after stage 1 surgery) 1 month after stage 2 surgery impression will be taken for crown prosthesis and crown will be delivered soon after it is prepared. All implants placement will be done by single trained surgeon at stage 1 and stage 2 surgery. In postoperative care antibiotics Amoxcillin 500mg tid for 5 days and analgesic diclofenac sodium 50mg + paracetamol 500mg tid for 5 days will be prescribed, along with chlorhexidine digluconate rinse twice daily for 2 weeks. Sutures will be removed after 10 days postoperatively. Each patient will be reinstructed for proper oral hygiene measures at each appointment, and re-examined at 6 months and 1 year. Soft and hard tissue evaluation will be performed at 6 months and 1year. Hard tissue evaluation will be done radiographically for the same study.

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 50.00 Year(s)(—)
性别
All

入选标准

  • Partially edentulous patient requiring 1 or more single implant supported crown 2)Absence of any local anatomical limitations 3)Patient willing for surgery.

排除标准

  • General contraindications to implant surgery 2)Local and systemic conditions affecting bone 3)Poor oral hygiene and motivation 4)Untreated periodontitis or acute/purulent infection in the area intended for implant placement 5)Unable to commit to 1-year follow-up 6)Treated or under treatment with intravenous amino-bisphosphonates 7)Lacking antagonistic occlusal surfaces for the study implants at implant loading 8)Implant site requiring major bone grafting procedures including sinus lift with lateral approach, minor augmentation procedures such as crestal sinus lift.

结局指标

主要结局

evaluation of implant

时间窗: at baseline that is after stage 1 surgery, after stage 2 surgery , 6 months and | 1 year

stability quotient

时间窗: at baseline that is after stage 1 surgery, after stage 2 surgery , 6 months and | 1 year

次要结局

  • to evaluate marginal bone level(at baseline to one year)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Shreya Singh

SMBT dental college and hospital

研究点 (1)

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