Sinus Floor AugmentationNCT06156488
Transcriptome Analysis of Human Bone Regeneration After Using an Anorganic Bovine Bone Graft With or Without a Combination of Polynucleotides and Hyaluronic Acid
A study testing Maxillary sinus floor augmentation in people with Sinus Floor Augmentation, run by Universidad de Granada at 1 site in Spain.
Trial summary
The goal of this clinical trial is to compare the expression of multiple genes related to bone regeneration in maxillary bone after being grafted with a commonly used biomaterial supplemented or not with a combination of hyaluronic acid and polynucleotides. 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?
- Maxillary sinus floor augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 4 Sep 2023to 30 Sep 2025
- 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
- Totally edentulous maxilla or 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).
- Heavy smokers (>10 cigarettes/day).
- 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
The goal of this clinical trial is to compare the expression of multiple genes related to bone regeneration in maxillary bone after being grafted with a commonly used biomaterial supplemented or not with a combination of hyaluronic acid and polynucleotides.
- Conditions
- Sinus Floor Augmentation
- Being tested
- Maxillary sinus floor augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary sinus floor augmentationProcedure or surgery
Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone + polynucleotides and hyaluronic acid
Maxillary sinus floor augmentationProcedure or surgery
Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone
| Study group | Role | What they receive |
|---|---|---|
| Anorganic bovine bone | Active comparator | Maxillary sinus floor augmentation grafted with anorganic bovine bone Receives: Procedure: Maxillary sinus floor augmentation |
| Anorganic bovine bone + polynucleotides and hyaluronic acid | Experimental | Maxillary sinus floor augmentation grafted with anorganic bovine bone + polynucleotides and hyaluronic acid Receives: Procedure: Maxillary sinus floor augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptome analysis
Transcriptome analysis of a sample of the regenerated bone will be performed 6 months after grafting immediately before implant placement
Measured: 6 months
Secondary outcomes (1)
Sinus floor height change
CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change
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 posted5 Dec 2023
- Study start4 Sep 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Model description
- Split-mouth design: each patient receives both treatment options at the same time in right and left sinuses
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Padial-Molina, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156488
- Sponsor's protocol ID
- 0003-N-23
- Status last verified
- Sep 2026
- First submitted
- 25 Nov 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3.
PubMed 35224778Galindo-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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptome Analysis of Human Bone Regeneration After Using an Anorganic Bovine Bone Graft With or Without a Combination of Polynucleotides and Hyaluronic Acid
- ClinicalTrials.gov ID
- NCT06156488
- Acronym / sponsor ID
- 0003-N-23
- Conditions
- Sinus Floor Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 5 Dec 2023 (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 goal of this clinical trial is to compare the expression of multiple genes related to bone regeneration in maxillary bone after being grafted with a commonly used biomaterial supplemented or not with a combination of hyaluronic acid and polynucleotides.
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: each patient receives both treatment options at the same time in right and left sinuses
| Arm | Type | Receives |
|---|---|---|
| Anorganic bovine bone | Active comparator | Procedure: Maxillary sinus floor augmentationMaxillary sinus floor augmentation grafted with anorganic bovine bone |
| Anorganic bovine bone + polynucleotides and hyaluronic acid | Experimental | Procedure: Maxillary sinus floor augmentationMaxillary sinus floor augmentation grafted with anorganic bovine bone + polynucleotides and hyaluronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Totally edentulous maxilla or 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).
- Heavy smokers (>10 cigarettes/day).
- 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 |
|---|---|---|
| Maxillary sinus floor augmentationMaxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone + polynucleotides and hyaluronic acid | Procedure or surgery | Anorganic bovine bone + polynucleotides and hyaluronic acid |
| Maxillary sinus floor augmentationMaxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone | Procedure or surgery | Anorganic bovine bone |
Primary outcome
Transcriptome analysis
Time frame: 6 months
Transcriptome analysis of a sample of the regenerated bone will be performed 6 months after grafting immediately before implant placement
1 secondary outcome
Sinus floor height change
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 14 Sep 2026.
- Background: PubMed 35224778Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3.
- 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: Undecided
Related trials for Sinus Floor Augmentation
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Enrolling by invitationPhase 1
Smart Scaffolds, Stronger Smiles Smarter Healing: AI-Boosted Multiphasic Scaffold Design for PDL Regeneration
Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation
Enrolling by invitation
Closed Sinus Augmentation With a Calcium Phosphosilicate Putty
Dental Implant, Maxillary Sinus Floor Augmentation
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
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 Maxillary sinus floor augmentation 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 3 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 14 Sep 2026. 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?
Transcriptome analysis (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 NCT06156488, which also lists 2 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 14 Sep 2026.