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临床试验/NCT06666595
NCT06666595招募中不适用

Clinical Outcome of Subcrestal Short Implant Versus Crestal Standard Length Implant to Retain Kennedy Class 1 Removable Partial Denture: A Split-mouth Study

Menoufia University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Bone loss

研究概览

简要总结

Objective: To report the implant survival rates, clinical, and radiographic outcomes of subcrestal short implant versus crestal standard length implant supported removable partial denture (RPD).

详细描述

30 individuals with at least 2 adjacent missing teeth bilaterally were included.to support class Ι RPD with conventional loading protocol were chosen for this research. Each participant received 2 implants in a split mouth design, one side received 1 subcrestal short implant and the contralateral side crestal standard length implant. Plaque index (PI), bleeding on probing (BOP), probing depth (PD), radiographic crestal bone level (CBL) and implant survival rate were evaluated. at implant placement (T0), restoration delivery (T1), and 3-year follow-up after loading (T2). MBL was calculated as the change in distance from the implant-abutment interface to the first radiographically visible bone-implant contact. A repeated-measures mixed ANOVA followed by a paired Student's t-test with the Bonferroni correction was used for statistical analysis. p < 0.05 was considered statistically significant

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •adult patients aged 50 years or older with class 1 RPD with missing mandibular molars at least and complaining from instability of the prosthesis were recruited.
  • •Medical history revealed no contraindication to implant therapy.
  • •Patients have an amount of bone nearly equal to 8 mm length above the inferior alveolar canal to receive a 6 mm short implant with 2 mm subcrestal to the bone level with sufficient bone width ≥ 8mm on one side and an amount of bone equal to or more than 8 mm to receive a standard-length implant of 7.5, 9, or 10.5 mm placed at crestal bone level with sufficient bone width ≥ 8mm on the contralateral side which was examined by CBCT.

排除标准

  • •Presence of active infection or inflammation in the areas intended for implant placement; *systemic diseases such as diabetes.
  • •Pregnant and lactating patients.
  • •Habit of severe bruxism or clenching.
  • •Treatment with therapeutic radiation to the head within the past 12 months.
  • •Treatment with bisphosphonate within the past 12 months.
  • •More than 10 cigarettes/day smoking habit.

研究组 & 干预措施

Subcrestal short implant

Active Comparator

Evaluation the amount of bone loss after one, two, and three years of function.

干预措施: Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis. (Procedure)

crestal standard length implant

Active Comparator

Evaluation the amount of bone loss after one, two, and three years of function.

干预措施: Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis. (Procedure)

结局指标

主要结局

Bone loss

时间窗: 3 years

Evaluation of crestal bone loss around implants will be performed by periapical digital radiograph using parallel technique to avoid distortion or elongation to the image.

次要结局

  • Plaque index (PI)(3 years)
  • Bleeding on probing (BOP)(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed El-Sawy

lecturer, Department of Prosthetic Dental Sciense, principle investigator

Menoufia University

研究点 (1)

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