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

Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357068
• Other study ID #: FOBblock
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 22, 2018

Study information

• Verified date: February 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 22, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Atrophy
• Alveolar Bone Loss
• Bone Resorption

Intervention

Procedure:
• Control
Control side will receive only perforations on recipient site, which is the conventional technique for bone blocks graft.
• Acid
Test side will receive treatment with citric acid (10%) for 30s at bone block surface and recipient site

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry	Bauru	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Rezende ML, Consolaro A, Sant'Ana AC, Damante CA, Greghi SL, Passanezi E. Demineralization of the contacting surfaces in autologous onlay bone grafts improves bone formation and bone consolidation. J Periodontol. 2014 May;85(5):e121-9. doi: 10.1902/jop.2013.130298. Epub 2013 Oct 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical bone block consolidation	Absence of fibrous tissue by clinical observation	5 months
Primary	Computerized tomography images bone block consolidation	Absence of images compatible to fibrosis in cone beam computerized tomography images	5 months
Primary	Histological bone block consolidation	Absence of fibrous tissue between bone block and recipient site in histological images.	5 months
Secondary	Bone width	Measurement of bone width in mm on cone beam computerized tomography. Ideal if >6 mm.	5 months