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

Not Applicable

Completed

• Conditions: Alveolar Bone Atrophy; Bone Resorption
• Interventions: Procedure: Control; Procedure: Acid

• Registration Number: NCT03357068
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-11-29
• Primary Completion: 2018-07-30
• Study Completion: 2018-12-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

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

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Autogenous bone block surgery without treatment of bone surfaces.
Acid	Acid	Autogenous bone block surgery with citric acid treatment of bone block and recipient site

Primary Outcome Measures

Name	Time	Method
Clinical bone block consolidation	5 months	Absence of fibrous tissue by clinical observation
Computerized tomography images bone block consolidation	5 months	Absence of images compatible to fibrosis in cone beam computerized tomography images
Histological bone block consolidation	5 months	Absence of fibrous tissue between bone block and recipient site in histological images.

Secondary Outcome Measures

Name	Time	Method
Bone width	5 months	Measurement of bone width in mm on cone beam computerized tomography. Ideal if \>6 mm.

Trial Locations

Locations (1)

Bauru School of Dentistry; 🇧🇷 Bauru, Sao Paulo, Brazil