Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects

Study Overview
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Brief Summary
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The aim of this study is to compare two pre-prosthetic surgical techniques for augmentation of vertical mandibular ridge defects in preparation for implant placement, the first using customized ceramic membranes and the second using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique).

Detailed Description
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Background: Expansion of the periosteum and soft tissue matrix by tenting has been described as a method of Guided Bone Regeneration (GBR) for reconstruction of atrophic alveolar ridges. Materials and Methods: The current study is a prospective controlled clinical trial, conducted on 14 patients, having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal. They are divided into 2 equal groups, each consisting of 7 patients. The first group receives customized ceramic membranes with a vertical height 5 mm above the crest of the ridge to tent out the soft tissue matrix, while in the second group, tenting of the soft tissue is done by fixation of two tenting screws, particulate bone graft is packed then covered by collagen membrane that is fixed by bone tacks (modified sausage technique).

Official Title
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Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects

Conditions
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Alveolar Ridge Enlargement

Intervention / Treatment
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* Device: customised ceramic sheets (Group 1)
* Combination Product: modified sausage technique (Group 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients of both genders with age range from 40 to 60 years, having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal and requiring prosthetic rehabilitation with dental implants. Exclusion Criteria: heavy smokers, patients undergoing radiotherapy or chemotherapy, those having infection or local lesions in the area of surgery, and patients with bone diseases which may compromise the results

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1(ceramic membrane)<br>using customized ceramic membranes for augmentation of vertical mandibular ridge defects in preparation for implant placement | Device: customised ceramic sheets (Group 1)<br>* guided bone regeneration<br>|
| Active Comparator: Group 2 (modified sausage technique)<br>using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique) for augmentation of vertical mandibular ridge defects in preparation for implant placement | Combination Product: modified sausage technique (Group 2)<br>* guided bone regeneration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean percentage of change of alveolar bone height | change of alveolar bone height after surgery | 6 months |