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临床试验/NCT05844540
NCT05844540已完成不适用

L- Shape Symphyseal Autogenous Bone Block for Alveolar Ridge Augmentation in Anterior Maxilla and Mandible

Mansoura University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
numerical rating scale for pain measurement

研究概览

简要总结

the aim of this study was to assess both horizontal and vertical alveolar bone augmentation for sever atrophied anterior maxilla and mandible, using L- shape autogenous bone block harvested from the symphysis. eleven partially edentulous patients seeking horizontal and vertical alveolar bone augmentation in the anterior maxilla or mandible were included in this study. For each patient, autogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible horizontally and vertically. Horizontal and vertical bone gain was measured by CBCT immediate postoperative and at 6months after grafting.

详细描述

A total of 11 partially edentulous patients needing extensive horizontal and vertical bone augmentation in the anterior maxilla or mandible were included in this study. The patients were recruited from the Outpatient Clinic of Oral and Maxillofacial Department, Faculty of Dentistry, Mansoura University.

Before the surgical operation, all patients were informed about the treatment options, the nature of the operation, and the probable postoperative sequelae. An informed consent was signed from each patient.

Preoperative assessment

  • Patients' medical status were carefully evaluated.
  • A thorough intraoral examination was done to evaluate oral hygiene, occlusion, and mucosa that covers the recipient and donor sites.
  • Preoperative CBCT was done for each patient to evaluate bone width and height in both the recipient and donor sites.

Surgical procedures Prophylactic antibiotic 600 mg Clindamycin (Clindam, Sigma, Egypt) was administered 1 hour before surgery. A thorough mouth rinsing using Chlorhexidine mouth wash (Hexitol, Adco, Egypt) for about 1 min was done immediately before surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Missed one or more upper or lower anterior teeth.
  • alveolar ridge with horizontal and vertical bone loss (class III according to Seibert et al(1983) classification).
  • age 18 to 45 years.
  • healthy oral mucosa, at least 3 mm keratinized mucosa.
  • no systemic diseases or drugs that affect bone healing.
  • no systemic or local conditions that contraindicate bone grafting or surgery.

排除标准

  • Patients with disturbed occlusion, inadequate inter-arch space.
  • patients with parafunction habits as bruxism or clenching.
  • pregnancy.
  • poor oral hygiene.

结局指标

主要结局

numerical rating scale for pain measurement

时间窗: 3 days post-surgery

Pain intensity was measured at three days after surgery on a 0 to 10 numerical rating scale in which 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, and 10 = the worst pain imaginable.

questionnaire for sensory disturbance

时间窗: with in 6 months

This was assessed by patients' complaint (patient questionnaire) to determine any change in subjective sensation in the lower lip, chin and mental area. if there is pain or not. if there is numbness or not.

infection and dehiscence of soft tissue

时间窗: with in 6 months

This was determined clinically by presence=1 or absence=0, of pus formation or graftb exposure.

width of the alveolar ridge

时间窗: immediate post-operative and after 6 months

CBCT cross section view was used for evaluation of alveolar ridge width and preoperatively, immediate postoperative (within one week after grafting), and at 6 months after grafting.

height of the alveolar ridge

时间窗: immediate post-operative and after 6 months

CBCT cross section view was used for evaluation of alveolar height preoperatively, immediate postoperative (within one week after grafting), and at 6 months after grafting.

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 (2)

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