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

February 24, 2023 updated by: Carla Andreotti Damante, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Bauru, Sao Paulo, Brazil, 17012-901
        • Bauru School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical bone block consolidation
Time Frame: 5 months
Absence of fibrous tissue by clinical observation
5 months
Computerized tomography images bone block consolidation
Time Frame: 5 months
Absence of images compatible to fibrosis in cone beam computerized tomography images
5 months
Histological bone block consolidation
Time Frame: 5 months
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
Time Frame: 5 months
Measurement of bone width in mm on cone beam computerized tomography. Ideal if >6 mm.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

July 30, 2018

Study Completion (Actual)

December 22, 2018

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOBblock

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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