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临床试验/NCT06637982
NCT06637982尚未招募不适用

Extended Platelet Rich Fibrin in Mandibular Alveolar Ridge Splitting With Simultaneous Implant Placement

Mansoura University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
试验地点
1
主要终点
implant stability

研究概览

简要总结

Thirty two healthy implants will be selected from the outpatient clinic of the oral and maxillofacial department of Mansoura university to be included in this study for replacement of lost posterior teeth with limited bone width.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age 18 years old and older.
  • Patient's cooperation, motivation and good oral hygiene.
  • Atrophic posterior mandible of horizontal alveolar dimension range between 3 - 6 mm at the crest, with minimum 10 mm vertical height from the alveolar crest to the superior border of the inferior alveolar canal.
  • Absence of undercuts in buccal aspect of the ridge.
  • Favorable occlusion and no parafunctional habits.
  • Patients able to comply with the required recall visits.
  • No gender preface in selection of the patients.
  • Acceptable inter-arch space for the future prosthesis.

排除标准

  • Any pathological condition at the site of surgery.
  • Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
  • Patient taking drugs that could affect bone healing process as immunosuppressive drugs and bisphosphonates.
  • Heavy smoking and alcoholism.
  • Parafunctional habits such as bruxism and clenching.
  • Signs of acute infection or pus discharge.
  • Untreated periodontal disease or bad oral hygiene.

结局指标

主要结局

implant stability

时间窗: 9 months

the stability of the implants will be evaluated by RFA with the Osstell Mentor device

alveolar ridge width

时间窗: 9 months

alveolar ridge width will be measured preoperative, immediate postoperative and after 9 months

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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