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临床试验/NCT06601816
NCT06601816已完成不适用

Comparison of Sinus Lifting Techniques Performed with Piezosurgery and a Surgical Guide, a Specially Designed Drill, and Conventional Drills in Terms Complications and Quality of Life

T.C. ORDU ÜNİVERSİTESİ2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
2
主要终点
Operation Time

研究概览

简要总结

This study aims to investigate the effects of various external sinus lifting techniques on patient comfort and perioperative complications.

详细描述

Patients who met the inclusion criteria and were admitted for posterior maxilla rehabilitation participated in this prospective, randomized, controlled clinical trial. The three methods used to lift the sinuses were randomized: piezosurgery using a surgical guide, a drill specifically made for lateral sinus lift, and traditional drills. Recorded were the duration of the procedure, accessibility, and intraoperative complications. During the first week following surgery, analgesic intake and pain using a visual analog scale (VAS) were assessed assessed. Preoperatively and on the second and seventh postoperative days, edema was assessed. Preoperatively and on the seventh postoperative day, the patient's quality of life using the OHIP-14 questionnaire, experiences, and expectations were evaluated.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Severe resorption or sinus pneumatization in the posterior maxilla that prevents standard implant treatment; class V or VI according to Cawood and Howell classification, patients with residual bone height less than 6 mm
  • Patients over 18 years of age
  • Patients without a history of reconstructive pre-prosthetic surgery or previous implant surgery
  • Patients with partial edentulism who have applied to our center for implant treatment and need sinus lifting
  • Patients with cone beam computed tomography (CBCT) taken within the last 1 month

排除标准

  • Patients with a history of systemic diseases (hematologic, neurologic, etc.) that may be contraindicated surgery
  • Patients who are pregnant or in lactation period
  • Patients with a history of immune system disorders and substance abuse
  • Patients with a history of radiotherapy in the head and neck region
  • Patients with existing maxillary sinus pathology or who have undergone surgery
  • Patients who smoke >10 cigarettes per day
  • Patients using antibiotics or steroids in the 30 days before surgery
  • Uncooperative patients who do not comply with the study protocol or follow-up regimen
  • Patients with perforation of the Schneiderian membrane

结局指标

主要结局

Operation Time

时间窗: from the osteotomy of the sinus window to completation of membrane elevation

The time from the osteotomy of the sinus window to completation of membrane elevation

次要结局

  • Analgesic Consumption(from 6 hours to 7 days postoperatively)
  • Patient Experience(7th postoperative day)
  • Pain(from 6 hours to postoperative 7 days)
  • Edema(on the 2nd and 7th days)
  • Quality of Life(preoperatively and on postoperative day 7)
  • Surgeon;s Comfort(Immediately after surgery)

研究者

发起方
T.C. ORDU ÜNİVERSİTESİ
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Melih Omezli

Professor

T.C. ORDU ÜNİVERSİTESİ

研究点 (2)

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