Sinus Floor AugmentationNCT03682315
Comparison of Phicogenic vs. Xenogeneic Biomaterial for Maxillary Sinus Floor Elevation
A study testing Biphasic phycogenic biomaterial and Xenograft bovine hydroxyapatite in people with Sinus Floor Augmentation, run by Universidad de Granada at 1 site in Spain.
Trial summary
The study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using a biphasic phicogenic biomaterial in comparison with anorganic bovine… 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?
- Biphasic phycogenic biomaterial and Xenograft bovine hydroxyapatite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Partially edentulous patients.
- Kennedy class I in the upper jaw.
- Less than 5 mm of residual crestal bone to the maxillary sinus.
- 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
1 site in 1 country.
About this study
Official title: Algae-derived Hydroxyapatite Behaviour as Bone Biomaterial in Comparison to Anorganic Bovine Bone. A Randomised Split-mouth Human Study.
The study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using a biphasic phicogenic biomaterial in comparison with anorganic bovine bone.
A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients are assigned to receive a mix of autogenous bone and a biphasic phycogenic biomaterial in one maxillary sinus and a mix of autogenous bone and xenograft bovine hydroxyapatite in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans are performed before sinus floor elevation and 6 months after the procedure to assess the bone gain. Bone core biopsies are obtained at the site of implant placement 6 months after the floor elevation. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
- Conditions
- Sinus Floor Augmentation
- Being tested
- Biphasic phycogenic biomaterial, Xenograft bovine hydroxyapatite
- Keywords
- Maxillary sinus augmentation, Sinus lift, Biomaterial, Anorganic bovine bone, Phicogenic biomaterial, Implant Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic phycogenic biomaterialDevice
Maxillary sinus floor elevation and bone grafting with the use of biphasic phycogenic biomaterial combined with autogenous cortical bone
Xenograft bovine hydroxyapatiteDevice
Maxillary sinus floor elevation and bone grafting with the use of xenograft bovine hydroxyapatite combined with autogenous cortical bone
| Study group | Role | What they receive |
|---|---|---|
| Biphasic phycogenic biomaterial | Active comparator | Biphasic phycogenic biomaterial and Autogenous cortical bone Receives: Device: Biphasic phycogenic biomaterial |
| Xenograft bovine hydroxyapatite | Experimental | Xenograft bovine hydroxyapatite and Autogenous cortical bone Receives: Device: Xenograft bovine hydroxyapatite |
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 calculate vertical bone height change from the crestal bone to the floor of the maxillary sinus
Measured: From surgery to 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 posted24 Sep 2018
- Study startSep 2016
- Primary completionApr 2018
- Study completionMay 2018
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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Galindo-Moreno, Universidad de Granada
- Investigators
- Pablo Galindo-Moreno, DDS, PhD, MS, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682315
- Sponsor's protocol ID
- 307CEIH2017
- Status last verified
- May 2023
- First submitted
- 21 Sep 2018
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- 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 22376122Galindo-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 29071736Galindo-Moreno P, Padial-Molina M, Lopez-Chaichio L, Gutierrez-Garrido L, Martin-Morales N, O'Valle F. Algae-derived hydroxyapatite behavior as bone biomaterial in comparison with anorganic bovine bone: A split-mouth clinical, radiological, and histologic randomized study in humans. Clin Oral Implants Res. 2020 Jun;31(6):536-548. doi: 10.1111/clr.13590. Epub 2020 Mar 6.
PubMed 32072685
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algae-derived Hydroxyapatite Behaviour as Bone Biomaterial in Comparison to Anorganic Bovine Bone. A Randomised Split-mouth Human Study.
- ClinicalTrials.gov ID
- NCT03682315
- Acronym / sponsor ID
- 307CEIH2017
- Conditions
- Sinus Floor Augmentation
- Keywords
- Maxillary sinus augmentation, Sinus lift, Biomaterial, Anorganic bovine bone, Phicogenic biomaterial, Implant Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 24 Sep 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 evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using a biphasic phicogenic biomaterial in comparison with anorganic bovine bone.
A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients are assigned to receive a mix of autogenous bone and a biphasic phycogenic biomaterial in one maxillary sinus and a mix of autogenous bone and xenograft bovine hydroxyapatite in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans are performed before sinus floor elevation and 6 months after the procedure to assess the bone gain. Bone core biopsies are obtained at the site of implant placement 6 months after the floor elevation. 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 |
|---|---|---|
| Biphasic phycogenic biomaterial | Active comparator | Device: Biphasic phycogenic biomaterialBiphasic phycogenic biomaterial and Autogenous cortical bone |
| Xenograft bovine hydroxyapatite | Experimental | Device: Xenograft bovine hydroxyapatiteXenograft bovine hydroxyapatite and Autogenous cortical bone |
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 in the upper jaw.
- Less than 5 mm of residual crestal bone to the maxillary sinus.
- 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 |
|---|---|---|
| Biphasic phycogenic biomaterialMaxillary sinus floor elevation and bone grafting with the use of biphasic phycogenic biomaterial combined with autogenous cortical bone | Device | Biphasic phycogenic biomaterial |
| Xenograft bovine hydroxyapatiteMaxillary sinus floor elevation and bone grafting with the use of xenograft bovine hydroxyapatite combined with autogenous cortical bone | Device | Xenograft bovine hydroxyapatite |
Primary outcome
Sinus floor height change
Time frame: From surgery to 6 months
CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change 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 23 May 2023.
- 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 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.
- Results publication: PubMed 32072685Galindo-Moreno P, Padial-Molina M, Lopez-Chaichio L, Gutierrez-Garrido L, Martin-Morales N, O'Valle F. Algae-derived hydroxyapatite behavior as bone biomaterial in comparison with anorganic bovine bone: A split-mouth clinical, radiological, and histologic randomized study in humans. Clin Oral Implants Res. 2020 Jun;31(6):536-548. doi: 10.1111/clr.13590. Epub 2020 Mar 6.
- 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.
Pablo Galindo-Moreno, DDS, PhD, MS principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biphasic phycogenic biomaterial and Xenograft bovine hydroxyapatite in people with Sinus Floor Augmentation, run by Universidad de Granada at 1 site 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 23 May 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 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: From surgery to 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 NCT03682315, 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 23 May 2023.