跳至主要内容
临床试验/NCT03731416
NCT03731416Unknown不适用

Ridge Augmentation in Atrophic Anterior Maxillary Ridges With Native Collagen Membrane and Anorganic Bovine Bone Derived Mineral With and Without Particulated Autogenous Bone Chips

Cairo University0 个研究点目标入组 10 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
主要终点
Height and width of bone gained

研究概览

简要总结

This study is aiming to evaluate clinically, radiographically ,and histologically GBR using collagen membrane in combination with a mixture of ABBM and autogenous particulated bone compared to collagen membrane with ABBM in atrophied anterior maxilla.

详细描述

Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques.6,8 To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Expanded polytetrafluoroethylene (e-PTFE) membranes are the most used non-resorbable membranes with the longest published follow-up, considering them the gold standard in the reconstructions of major horizontal bone defects. However, a second surgery is needed to remove them and they may get exposed in the oral cavity and contaminate with possible infection and graft loss. Conversely, the resorbable membranes most advantages are an ability to merge with the host tissues, as well as a rapid resorption in case of exposure, thereby reducing the risk of bacterial contamination. Resorbable membranes in combination with particulated anorganic bovine bone (ABB) can be used for the augmentation of horizontally deficient ridges. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

盲法说明

Each patient will be given a code by the researcher and the observers will be blind to which group this case belong.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with atrophied anterior maxillary ridge area.
  • Age: 18 years and older.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicate bone augmentation

排除标准

  • • Heavy smokers more than 20 cigarettes per day.(32)
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems.
  • Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
  • Pregnant or nursing women.
  • Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
  • Patient with previous history of radiotherapy.

研究组 & 干预措施

GBR by xenograft

Placebo Comparator
  • Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
  • Intra operative procedures (for both groups) followed by CBCT will be taken for every patient.
  • Local anesthesia will be given to the patient.
  • Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
  • Flap will be done.
  • In the study group: bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
  • • The site will then be copiously irrigated with saline in preparation for closure.
  • The flap will then be closed using interrupted 4/0 resorbable sutures.

干预措施: GBR by xenograft and autogenous bone (Procedure)

GBR by xenograft ,autogenous bone

Active Comparator

Intervention In the control group:first crestal incision then two vertical incisions by blade 15c,full thickness flap reflection, bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area(atrophic maxilla) then covered by a native collagen membrane which will be stabilized by tacks.Then The flap will then be closed using interrupted 4/0 resorbable sutures.

干预措施: GBR by xenograft and autogenous bone (Procedure)

结局指标

主要结局

Height and width of bone gained

时间窗: 6 months

Height and width of bone gained in mm by CBCT

次要结局

  • Bone area percentage(6 months)

研究者

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

hossam samir mohamed ahmed elbaha

Principal Investigator(doctor)

Cairo University

相似试验