Reconstruction of Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using Collagen Membrane

Study Overview
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Brief Summary
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Is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in Maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quality and bone quantity?

Detailed Description
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Soft tissue dehiscence could result due to flap irritation as a result of, closure under tension, intraoperative or postoperative recipient site infection, postoperative edema, which in turns compromises stability of onlay bone blocks thus osseintegration of bone block. Any attempt of bone recontouring and resuturing fails since there is no vascular bed. Ideal requirements of barrier membranes are, they should be biological compatible, they must act as a barrier membrane, unwanted fibroblasts should be hindered from entrance while allowing diffusion of nutrients, tissue integration (biological adhesion), tissues should be able to grow into the membrane but not through it. Space maintainer, it should be sufficiently stiff, so as not to collapse into the underlying particulate bone under the pressure of soft tissue and it should be ease in its manipulation, adaptation and handling, as for example, collagen membrane. Some types of collagen membrane, contain some degrees of stretchability.

Official Title
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Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using Collagen Membrane

Conditions
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Bone Augmentation

Intervention / Treatment
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* Procedure: Onlay bone block covered using collagen membrane
* Procedure: Onlay bone block without collagen membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with maxillary residual alveolar bone height not less than 8 mm. Alveolar bone width from less than or equal 5 mm. Both sexes. At least missing single tooth. Previous Failed Implants. Previous Failed Grafting. Exclusion Criteria: Heavy smokers more than 20 cigarettes per day. Patients with alcohol abuse Patients with narcotic abuse. Patients with bone disease that may affect normal healing, example; hyperparathyroidism. Patients had radiotherapy and chemotherapy in head and neck. Patients had neoplasms in sites to be grafted. 18 Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\dl. Pregnant females. Patients with Para functional habits, apprehensive and non-cooperative. Bone pathology related to the site to be grafted. Psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations. Intraoral soft and hard tissue pathology. Systemic condition that contraindicate implant placement. Under the age of 18 years.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Onlay bone block covered using collagen membrane<br>The onlay bone block (harvested from mandibular intra oral sites) on top of a mixture of particulate autogenous bone and particulate xenogenic bone (assembly going to be fixed by at least 2 micro screws of diameter 1.5 mms and length 13 mms, to avoid micro movements of onlay bone block) covered by collagen membrane, stabilized by resorbable suture and fixed by tacs. | Procedure: Onlay bone block covered using collagen membrane<br>* The ratio is 40% of xenogenic bone particles (low resorption rate) to 60% of autogenous bone particles (contains viable cells) to be placed in recipient decorticated site and covered by onlay bone block..<br>|
| Active Comparator: Onlay bone block without collagen membrane<br>The onlay bone block (harvested from mandibular intra oral sites) on top of a mixture of particulate autogenous bone and particulate xenogenic bone (assembly going to be fixed by at least 2 micro screws of diameter 1.5 mms and length 13 mms, to avoid micro movements of onlay bone block). | Procedure: Onlay bone block without collagen membrane<br>* Onlay bone block without collagen membrane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of bone gain. | Measured using linear measurements from Cone Beam Computed Tomography (CBCT) in millimeters (mm). | after 5 months from ridge augmentation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Quality. | Measured using Image Analyser Computer System using Histomorphometric method (area percent micrometer square) and optical density | after 5 months from ridge augmentation. |