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

NCT03357068 — Not applicable, Completed, 10 participants, University of Sao Paulo

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

Registry	NCT03357068
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	10 (Actual)
Sponsor	University of Sao Paulo (Other)
Conditions	Alveolar Bone Atrophy, Bone Resorption
Interventions	Control, Acid (Procedure)
Dates	start 2017-07-01, primary completion 2018-07-30, completion 2018-12-22, first posted 2017-11-29, last updated 2023-02-27
Locations	1 site in Brazil

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Control	Active comparator	Procedure: Control	Autogenous bone block surgery without treatment of bone surfaces.
Acid	Experimental	Procedure: Acid	Autogenous bone block surgery with citric acid treatment of bone block and recipient site

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

+Outcome measures

Primary outcomes

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 outcomes

Bone width [5 months]: Measurement of bone width in mm on cone beam computerized tomography. Ideal if >6 mm.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Bauru School of Dentistry	Bauru, São Paulo	Brazil

+Publications

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. PMID 24171500

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