Guided Bone Regeneration in Atrophic Anterior Maxillary Ridges

Not Applicable

• Conditions: Bone Resorption Disorder
• Interventions: Procedure: GBR by xenograft and autogenous bone

• Registration Number: NCT03731416
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-11-03
• Study First Submitted QC: 2018-11-03
• Study First Posted: 2018-11-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30
• Study Start: 2019-10-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GBR by xenograft	GBR by xenograft and autogenous bone	* 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.
GBR by xenograft ,autogenous bone	GBR by xenograft and autogenous bone	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.

Primary Outcome Measures

Name	Time	Method
Height and width of bone gained	6 months	Height and width of bone gained in mm by CBCT

Secondary Outcome Measures

Name	Time	Method
Bone area percentage	6 months	Bone area percentage % by Histo-morphometric analysis