Back to resultsEffect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans
Primary Purpose
Alveolar Bone Atrophy, Bone Resorption
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Control
Acid
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Atrophy
Eligibility Criteria
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
Sites / Locations
- Bauru School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Acid
Arm Description
Autogenous bone block surgery without treatment of bone surfaces.
Autogenous bone block surgery with citric acid treatment of bone block and recipient site
Outcomes
Primary Outcome Measures
Clinical bone block consolidation
Absence of fibrous tissue by clinical observation
Computerized tomography images bone block consolidation
Absence of images compatible to fibrosis in cone beam computerized tomography images
Histological bone block consolidation
Absence of fibrous tissue between bone block and recipient site in histological images.
Secondary Outcome Measures
Bone width
Measurement of bone width in mm on cone beam computerized tomography. Ideal if >6 mm.
Full Information
NCT ID
NCT03357068
First Posted
November 22, 2017
Last Updated
February 24, 2023
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03357068
Brief Title
Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans
Official Title
Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans: Qualitative, Quantitative and Immunohistochemical Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
December 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Atrophy, Bone Resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split mouth design - one side of mouth is test group, other side is control group
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Autogenous bone block surgery without treatment of bone surfaces.
Arm Title
Acid
Arm Type
Experimental
Arm Description
Autogenous bone block surgery with citric acid treatment of bone block and recipient site
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Control side will receive only perforations on recipient site, which is the conventional technique for bone blocks graft.
Intervention Type
Procedure
Intervention Name(s)
Acid
Intervention Description
Test side will receive treatment with citric acid (10%) for 30s at bone block surface and recipient site
Primary Outcome Measure Information:
Title
Clinical bone block consolidation
Description
Absence of fibrous tissue by clinical observation
Time Frame
5 months
Title
Computerized tomography images bone block consolidation
Description
Absence of images compatible to fibrosis in cone beam computerized tomography images
Time Frame
5 months
Title
Histological bone block consolidation
Description
Absence of fibrous tissue between bone block and recipient site in histological images.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Bone width
Description
Measurement of bone width in mm on cone beam computerized tomography. Ideal if >6 mm.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bauru School of Dentistry
City
Bauru
State/Province
Sao Paulo
ZIP/Postal Code
17012-901
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24171500
Citation
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.
Results Reference
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Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans
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