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临床试验/NCT07329179
NCT07329179已完成不适用

Crestal Sinus Lifting Using Densah Burs Versus Lateral Window Technique at Residual Alveolar Ridge Height 3-5 mm With Simultaneous Implant Placement

Delta University for Science and Technology1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年2月5日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
change from baseline in pain, as measured by Numerical Rating Scale (NRS)

研究概览

简要总结

The aim of the study was to assess the clinical and radiographic outcomes of crestal sinus lifting using densah burs versus lateral window technique in vertically deficient posterior maxilla with simultaneous implant placement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Patient medically free from systemic, immunologic or debilitating diseases or local conditions that could affect normal bone healing and/or implant placement.
  • 2. Patient with good oral hygiene.
  • Age from 18 to 55 years.
  • Partially edentulous patients with missed one or more of maxillary posterior teeth with residual alveolar ridge height 3-5 mm and a minimal width of the alveolar ridge 7 mm in the region of the planned implant site.
  • 5. Patients' edentulous ridges covered with optimal width of keratinized mucosa (<3 mm) with no signs of inflammation, ulceration of scar tissue.
  • 6. No history of parafunctional habits.
  • Patients were ready to comply with the follow-up and maintenance program.
  • Sufficient inter arch space for prothesis.

排除标准

  • Patients with clinical or radiographic evidence of rhinosinusitis or any other pathology in the maxillary sinus.
  • 2. Smokers.

结局指标

主要结局

change from baseline in pain, as measured by Numerical Rating Scale (NRS)

时间窗: Baseline, 7 days

Pain was evaluated postoperatively at the day of surgery, 3rd and 7th day post-surgically Numerical Rating Scale (NRS). Numerical Rating Scale (NRS) is a simple, widely used tool, typically an 11-point scale (0-10), where patients rate their pain intensity, with 0 meaning "no pain" and 10 meaning "worst imaginable pain,".

change from baseline of edema

时间窗: baseline, 7 days

Edema was evaluated with the aid of tape measure (in centimeters). Three measurements were performed on the patient's operated site preoperatively, 3rd and 7th day after surgery. The evaluation of edema was done by subtracting the total value of the three measurements obtained postoperatively (at 3rd and 7th day) from the total value of the three measurements obtained at pre-operative baseline. The three measuring lines are: 1. Lateral corner of the eye-angle of the mandible. 2. Tragus-outer corner of the mouth. 3. Tragus pogonion.

change from baseline in Grafted sinus height (GSH)

时间窗: baseline, 12 months

CBCT was made preoperatively, immediately after sinus augmentation (T0) and 6 months after loading (T12) for evaluation of Grafted sinus height (GSH): the distance between the original sinus floor to the new sinus floor regarding crestal cortical line.

change of implant stability, as measured by osstell

时间窗: baseline, 12 months

Stability was measured with osstell (ISQ) immediately after implant placement (T0) after 12 months (T12). ISQ is a scale that ranges from 1 to 100 and is used to assess implant stability. Scales greater than 70 ISQ indicate a high level of stability, scales between 60 and 69 means medium stability and scales \>60 ISQ are considered as low stability.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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