Sinus Floor AugmentationNCT03474627
PLGA-coated Biphasic Calcium Phosphate in Sinus Lift
A study testing Non-coated HA/TCP particles and PLGA-coated HA/TCP particles in people with Sinus Floor Augmentation, run by Universidad de Granada at 2 sites in Spain.
Trial summary
The study aims to investigate the radiological and histomorphometric results of the use of PLGA-coated biphasic calcium phosphate granules in sinus floor elevation, to analyze the underlying molecular processes by immunohistochemical staining, and to evaluate the handling of the biomaterial and the in situ hardening… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Floor Augmentation
- What is being tested?
- Non-coated HA/TCP particles and PLGA-coated HA/TCP particles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesSpain
- Study dates
- Feb 2012to Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Partially edentulous patients.
- Kennedy class I or II in the upper jaw, from first premolar to second molar.
- Less than 5 mm of residual crestal bone.
- Need for the replacement of teeth with dental implants.
Who cannot join
- Sinus pathology (sinusitis, mucocele, cysts).
- Smokers.
- Previous long-term (>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University of Granada
Granada, 18071
Universidad de Valencia
Valencia, 46010
About this study
Official title: Sinus Floor Elevation Using Particulate and in Situ Hardening Biphasic Calcium Phosphate Bone Graft Substitutes: A Prospective Histological and Radiological Study
The study aims to investigate the radiological and histomorphometric results of the use of PLGA-coated biphasic calcium phosphate granules in sinus floor elevation, to analyze the underlying molecular processes by immunohistochemical staining, and to evaluate the handling of the biomaterial and the in situ hardening properties.
A randomized clinical study is designed to include patients in need of two-stage sinus floor elevation. Patients are assigned to receive either PLGA-coated biphasic calcium phosphate particles (group I) or the equivalent but non-coated particles (group II). CBCT scans are performed before and 6 months after the procedure to assess the bone height gain. At the time of implant placement, bone core biopsies are obtained at the site of implant placement. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
- Conditions
- Sinus Floor Augmentation
- Being tested
- Non-coated HA/TCP particles, PLGA-coated HA/TCP particles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-coated HA/TCP particlesDevice
Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft
PLGA-coated HA/TCP particlesDevice
Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating
| Study group | Role | What they receive |
|---|---|---|
| Non-coated HA/TCP particles | Active comparator | Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft Receives: Device: Non-coated HA/TCP particles |
| PLGA-coated HA/TCP particles | Experimental | Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating Receives: Device: PLGA-coated HA/TCP particles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus floor height change
CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to measure vertical bone height from the crestal bone to the floor of the maxillary sinus.
Measured: 6 months
Secondary outcomes (3)
Area of new mineralized tissue
Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
Measured: 6 months
Area of non-mineralized tissue
Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
Measured: 6 months
Area of remaining graft particles
Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study startFeb 2012
- Primary completionMar 2014
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sinus Floor AugmentationStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, Pablo Galindo-Moreno, Universidad de Granada
- Investigators
- Antonio J Flichy-Fernandez, DDS, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474627
- Sponsor's protocol ID
- H1452514461215
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galindo-Moreno P, Hernandez-Cortes P, Mesa F, Carranza N, Juodzbalys G, Aguilar M, O'Valle F. Slow resorption of anorganic bovine bone by osteoclasts in maxillary sinus augmentation. Clin Implant Dent Relat Res. 2013 Dec;15(6):858-66. doi: 10.1111/j.1708-8208.2012.00445.x. Epub 2012 Feb 29.
PubMed 22376122Ortega-Oller I, Del Castillo-Santaella T, Padial-Molina M, Galindo-Moreno P, Jodar-Reyes AB, Peula-Garcia JM. Dual delivery nanosystem for biomolecules. Formulation, characterization, and in vitro release. Colloids Surf B Biointerfaces. 2017 Nov 1;159:586-595. doi: 10.1016/j.colsurfb.2017.08.027. Epub 2017 Aug 24.
PubMed 28854415Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12.
PubMed 17355356Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-Barbero JE, Ata-Ali J, O Valle F. Histopathological comparison of healing after maxillary sinus augmentation using xenograft mixed with autogenous bone versus allograft mixed with autogenous bone. Clin Oral Implants Res. 2018 Feb;29(2):192-201. doi: 10.1111/clr.13098. Epub 2017 Oct 26.
PubMed 29071736
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinus Floor Elevation Using Particulate and in Situ Hardening Biphasic Calcium Phosphate Bone Graft Substitutes: A Prospective Histological and Radiological Study
- ClinicalTrials.gov ID
- NCT03474627
- Acronym / sponsor ID
- H1452514461215
- Conditions
- Sinus Floor Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- Feb 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 22 Mar 2018 (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.
The study aims to investigate the radiological and histomorphometric results of the use of PLGA-coated biphasic calcium phosphate granules in sinus floor elevation, to analyze the underlying molecular processes by immunohistochemical staining, and to evaluate the handling of the biomaterial and the in situ hardening properties.
A randomized clinical study is designed to include patients in need of two-stage sinus floor elevation. Patients are assigned to receive either PLGA-coated biphasic calcium phosphate particles (group I) or the equivalent but non-coated particles (group II). CBCT scans are performed before and 6 months after the procedure to assess the bone height gain. At the time of implant placement, bone core biopsies are obtained at the site of implant placement. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-coated HA/TCP particles | Active comparator | Device: Non-coated HA/TCP particlesBiphasic hydroxyapatite and beta-tricalcium phosphate bone graft |
| PLGA-coated HA/TCP particles | Experimental | Device: PLGA-coated HA/TCP particlesBiphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Partially edentulous patients.
- Kennedy class I or II in the upper jaw, from first premolar to second molar.
- Less than 5 mm of residual crestal bone.
- Need for the replacement of teeth with dental implants.
Key exclusion criteria (3 listed)
- Sinus pathology (sinusitis, mucocele, cysts).
- Smokers.
- Previous long-term (>3 months) use of drugs known to affect bone metabolism, such as 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 |
|---|---|---|
| Non-coated HA/TCP particlesMaxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft | Device | Non-coated HA/TCP particles |
| PLGA-coated HA/TCP particlesMaxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating | Device | PLGA-coated HA/TCP particles |
Primary outcome
Sinus floor height change
Time frame: 6 months
CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to measure vertical bone height from the crestal bone to the floor of the maxillary sinus.
3 secondary outcomes
Area of new mineralized tissue
Time frame: 6 months
Area of non-mineralized tissue
Time frame: 6 months
Area of remaining graft particles
Time frame: 6 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 22 Mar 2018.
- Background: PubMed 22376122Galindo-Moreno P, Hernandez-Cortes P, Mesa F, Carranza N, Juodzbalys G, Aguilar M, O'Valle F. Slow resorption of anorganic bovine bone by osteoclasts in maxillary sinus augmentation. Clin Implant Dent Relat Res. 2013 Dec;15(6):858-66. doi: 10.1111/j.1708-8208.2012.00445.x. Epub 2012 Feb 29.
- Background: PubMed 28854415Ortega-Oller I, Del Castillo-Santaella T, Padial-Molina M, Galindo-Moreno P, Jodar-Reyes AB, Peula-Garcia JM. Dual delivery nanosystem for biomolecules. Formulation, characterization, and in vitro release. Colloids Surf B Biointerfaces. 2017 Nov 1;159:586-595. doi: 10.1016/j.colsurfb.2017.08.027. Epub 2017 Aug 24.
- Background: PubMed 17355356Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12.
- Background: PubMed 29071736Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-Barbero JE, Ata-Ali J, O Valle F. Histopathological comparison of healing after maxillary sinus augmentation using xenograft mixed with autogenous bone versus allograft mixed with autogenous bone. Clin Oral Implants Res. 2018 Feb;29(2):192-201. doi: 10.1111/clr.13098. Epub 2017 Oct 26.
- 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.
Antonio J Flichy-Fernandez, DDS principal investigator
University of Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-coated HA/TCP particles and PLGA-coated HA/TCP particles in people with Sinus Floor Augmentation, run by Universidad de Granada at 2 sites in Spain.
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 4 inclusion and 3 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Sinus floor height change (time frame: 6 months). 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 NCT03474627, which also lists 4 linked publications.
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 22 Mar 2018.