Guided Bone Regeneration Versus Bone Block Grafting

Study Overview
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Brief Summary
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The purpose of this study is to analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft.

Official Title
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Randomized Controlled Clinical Trial Comparing the Clinical Measures and the Radiographical Volumetric Outcomes Assessed by Cone Beam Computed Tomography of Guided Bone Regeneration Versus Bone Block Grafting

Conditions
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Atrophy; Bone

Intervention / Treatment
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* Procedure: Khoury technique
* Procedure: Guided bone regeneration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in need of an implant-supported rehabilitation Patients requiring bone regeneration Healthy patients Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15% Sufficient mesiodistal and interocclusal space At least 6 months of follow-up Exclusion Criteria: An American Society of Anesthesiologists physical status classification ≥ III General contraindications for surgical treatment or implant placement Untreated periodontitis Smoking Excessive alcohol consumption Any drug or medication known to affect oral status and bone turnover or contraindicate surgical treatment No residual keratinized tissue at the experimental area Unwillingness to return for follow-up examinations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Guided bone regeneration<br>Patients will be treated with guided bone regeneration. | Procedure: Guided bone regeneration<br>* the membrane and the bone granules will be used to perform the guided bone regeneration technique.<br>|
| Experimental: Bone block<br>Patients will be treated with bone blocks using the Khoury technique. | Procedure: Khoury technique<br>* the bone block will be used following the principles of the Khoury technique to augment the bone volume.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone volume | the bone volume will be analyzed with the Cone Beam Computed Tomography scan | 6 Months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal parameters | the periodontal parameters will be analyzed clinically with the periodontal probe and measured in millimeters. All the periodontal parameters will be combined to describe the periodontal status of the patient. | 6 Months follow up | 
| Wound healing | the wound healing will be recorded with the Early Wound Healing Score (EHS) ranging from 0 to 10 which includes the following parameters: clinical signs of re-epithelialization: 0 points, visible distance between incision margins; 3 points, incision margins in contact; 6 points, merged incision margins. clinical signs of haemostasis: 0 points, bleeding at the incision margins; 1 point, presence of fibrin at the incision margins; 2 points, absence of fibrin on the incision margins. clinical signs of inflammation: 0 points, redness involving >50% of the incision length and/or pronounced swelling; 1 point, redness involving <50% of the incision length; 2 points, absence of redness along the incision length. | 2 weeks follow up | 
| Histological analysis | The histological analysis will be performed harvesting a sample during the implant placement. Bone biopsies including both native and regenerated bone will be subjected to digital scanning to analyze the characteristics of newly formed bone, the remaining grafted material, integration of grafted material with newly formed bone, soft tissue, and local inflammation. Histomorphometric analyses will be performed to measure the following parameters: bone tissue area , graft material area , soft tissue area. Bone tissue area , graft material area , soft tissue area will be expressed relative to the total area. | 6 Months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Regeneration