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临床试验/CTRI/2025/10/096168
CTRI/2025/10/096168尚未招募4 期

Clinico-radiological evaluation of endosinus bone gain with and without grafting in indirect sinus floor augmentation using osseodensification concept: An in vivo study

Dr Ankita1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Endosinus bone gain: - To measure the extent of endosinus bone gain achieved in the

研究概览

简要总结

This in vivo study titled “Clinico-radiological evaluation of endosinus bone gain with and without grafting in indirect sinus floor augmentation using osseodensification concept” aims to compare the outcomes of sinus lift procedures performed with and without xenograft materials using the osseodensification technique. It evaluates bone density, primary implant stability, and endosinus bone gain through CBCT analysis. Twenty patients with residual bone height between 4–8 mm in the posterior maxilla will be included. The study seeks to determine whether osseodensification alone can achieve comparable bone augmentation and implant stability to that achieved with additional grafting.

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

  • 1.Patients with missing tooth from maxillary posterior region with residual bone height lesser than 8mm and more than 4mm
  • Patients with good oral hygiene and healthy periodontal status.
  • 3.No acute infection is present.
  • 4.Informed and signed consent.

排除标准

  • Uncontrolled diabetes (HBA1c greater than 7.5%) 2.Treated or under treatment with bisphosphonate for any medical illness 3.Irradiated in the head and neck area in the last 5 years
  • Pregnant or breast feeding 5.Substance abusers
  • Psychiatric problems or unrealistic expectations
  • Patient not fully able to comply with the study protocol Local exclusion criteria consisted of the following 1.Residual bone height greater than 8mm
  • Maxillary sinus conditions contraindicating sinus floor elevation 3.Poor oral hygiene and motivation (Full Mouth Plaque Score greater than 20% and or Full Mouth Bleeding Score greater than 10%).

结局指标

主要结局

Endosinus bone gain: - To measure the extent of endosinus bone gain achieved in the

时间窗: 4 Months

grafted and non-grafted groups through CBCT

时间窗: 4 Months

次要结局

  • 1. Bone density assessment: - To assess changes in bone density at the implant site(following osseodensification in both grafted and non-grafted groups using CBCT)

研究者

发起方
Dr Ankita
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ankita

Faculty of dental sciences, IMS, BHU

研究点 (1)

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