Clinical trial NCT03731416: Guided Bone Regeneration in Atrophic Anterior Maxillary Ridges
Official title: Ridge Augmentation in Atrophic Anterior Maxillary Ridges With Native Collagen Membrane and Anorganic Bovine Bone Derived Mineral With and Without Particulated Autogenous Bone Chips
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption Disorder
Keywords: GBR, autogenous bone, xenograft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly divided into 2 equal groups
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* • 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.

Primary outcomes:
measure: Height and width of bone gained
timeFrame: 6 months
Secondary outcomes:
measure: Bone area percentage
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: hossam Elbaha
role: STUDY_CHAIR
References:
citation: Meloni SM, Jovanovic SA, Urban I, Canullo L, Pisano M, Tallarico M. Horizontal Ridge Augmentation using GBR with a Native Collagen Membrane and 1:1 Ratio of Particulated Xenograft and Autologous Bone: A 1-Year Prospective Clinical Study. Clin Implant Dent Relat Res. 2017 Feb;19(1):38-45. doi: 10.1111/cid.12429. Epub 2016 Jun 9.