Alveolar Bone AtrophyNCT03357068
Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans
A study testing Acid in people with Alveolar Bone Atrophy and Bone Resorption, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alveolar Bone Atrophy, Bone Resorption
- What is being tested?
- Acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2017to 22 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Systemic disease that impede surgical procedure as blood diseases, endocrine diseases, impaired coagulation
- Smokers
- Pregnant women
- Patients receiving radiotherapy or chemotherapy
- Patients using bisphosphonates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alveolar Bone Atrophy, Bone Resorption
- Being tested
- Control, Acid
- Medical subject headings
- Alveolar Bone Loss, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
Control side will receive only perforations on recipient site, which is the conventional technique for bone blocks graft.
AcidProcedure or surgery
Test side will receive treatment with citric acid (10%) for 30s at bone block surface and recipient site
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Autogenous bone block surgery without treatment of bone surfaces. Receives: Procedure: Control |
| Acid | Experimental | Autogenous bone block surgery with citric acid treatment of bone block and recipient site Receives: Procedure: Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical bone block consolidation
Absence of fibrous tissue by clinical observation
Measured: 5 months
Computerized tomography images bone block consolidation
Absence of images compatible to fibrosis in cone beam computerized tomography images
Measured: 5 months
Histological bone block consolidation
Absence of fibrous tissue between bone block and recipient site in histological images.
Measured: 5 months
Secondary outcomes (1)
Bone width
Measurement of bone width in mm on cone beam computerized tomography. Ideal if >6 mm.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Jul 2017
- Primary completion30 Jul 2018
- Study completion22 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone AtrophyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split mouth design - one side of mouth is test group, other side is control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Andreotti Damante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357068
- Sponsor's protocol ID
- FOBblock
- Status last verified
- Feb 2023
- First submitted
- 22 Nov 2017
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24171500
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans: Qualitative, Quantitative and Immunohistochemical Analysis
- ClinicalTrials.gov ID
- NCT03357068
- Acronym / sponsor ID
- FOBblock
- Conditions
- Alveolar Bone Atrophy, Bone Resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 22 Dec 2018 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth design - one side of mouth is test group, other side is control group
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: ControlAutogenous bone block surgery without treatment of bone surfaces. |
| Acid | Experimental | Procedure: AcidAutogenous bone block surgery with citric acid treatment of bone block and recipient site |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- Systemic disease that impede surgical procedure as blood diseases, endocrine diseases, impaired coagulation
- Smokers
- Pregnant women
- Patients receiving radiotherapy or chemotherapy
- Patients using bisphosphonates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlControl side will receive only perforations on recipient site, which is the conventional technique for bone blocks graft. | Procedure or surgery | Control |
| AcidTest side will receive treatment with citric acid (10%) for 30s at bone block surface and recipient site | Procedure or surgery | Acid |
Primary outcome
Clinical bone block consolidation
Time frame: 5 months
Absence of fibrous tissue by clinical observation
Computerized tomography images bone block consolidation
Time frame: 5 months
Absence of images compatible to fibrosis in cone beam computerized tomography images
Histological bone block consolidation
Time frame: 5 months
Absence of fibrous tissue between bone block and recipient site in histological images.
1 secondary outcome
Bone width
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 24171500Rezende 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acid in people with Alveolar Bone Atrophy and Bone Resorption, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical bone block consolidation (time frame: 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03357068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.