Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans

Study Overview
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Brief Summary
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This study evaluates the effect of citric acid demineralization in autogenous bone blocks consolidation. Half of participants will receive citric acid treatment at the bone block and recipient site. Other half will receive no demineralization treatment.

Detailed Description
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Autogenous bone grafts are indicated in areas where there is not enough bone height and/or width for implant installation. Treatment of bone surfaces with citric acid, promote a slight demineralization on surface that mimic natural processes of bone demineralization by osteoclasts. Thus, this treatment could accelerate the process of autogenous bone block consolidation to its recipient site.

Official Title
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Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans: Qualitative, Quantitative and Immunohistochemical Analysis

Conditions
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Alveolar Bone Atrophy, Bone Resorption

Intervention / Treatment
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* Procedure: Control
* Procedure: Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of atrophic anterior maxilla (width 1.5 to 4 mm) Absence of active periodontal disease. Enough bone width on donor sites (oblique line or ment) Exclusion Criteria: Systemic disease that impede surgical procedure as blood diseases, endocrine diseases, impaired coagulation Smokers Pregnant women Patients receiving radiotherapy or chemotherapy Patients using bisphosphonates

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Split mouth design - one side of mouth is test group, other side is control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Autogenous bone block surgery without treatment of bone surfaces. | Procedure: Control<br>* Control side will receive only perforations on recipient site, which is the conventional technique for bone blocks graft.<br>|
| Experimental: Acid<br>Autogenous bone block surgery with citric acid treatment of bone block and recipient site | Procedure: Acid<br>* Test side will receive treatment with citric acid (10%) for 30s at bone block surface and recipient site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical bone block consolidation | Absence of fibrous tissue by clinical observation | 5 months | 
| Computerized tomography images bone block consolidation | Absence of images compatible to fibrosis in cone beam computerized tomography images | 5 months | 
| Histological bone block consolidation | Absence of fibrous tissue between bone block and recipient site in histological images. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone width | Measurement of bone width in mm on cone beam computerized tomography. Ideal if >6 mm. | 5 months |