Sinus Floor ElevationNCT07182929

Radiographic Assessment of Deproteinized Porcine Versus Bovine Bone Mineral in Sinus Augmentation

An observational study of Sinus Floor Elevation and Sinus Floor Augmentation, run by Guoli Yang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of this retrospective study is to compare the radiographic outcomes of deproteinized porcine bone mineral (DPBM) and deproteinized bovine bone mineral (DBBM) following lateral sinus floor augmentation (LSFA) with simultaneous implant placement. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Sinus Floor Elevation, Sinus Floor Augmentation
What is being tested?: Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone Mineral
Type of treatment: Surgery or procedure
How many people: 56 participants
Where: 1 siteChina
Study dates: 1 Jan 2024to 1 Jul 2025
Phase: Observational
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients who received LSFA with simultaneous implant placement from June 2022 to June 2024 at the Stomatology Hospital, Zhejiang University School of Medicine, were screened for eligibility. All patients underwent preoperative clinical, radiographic examinations and laboratory tests. Eligible patients subsequently received LSFA performed by experienced implant surgeons following the standardized surgical protocol.

Who may be able to join

Aged between 18 and 80 years;
Single or multiple missing teeth in the posterior maxilla with a healing period of at least 3 months;
Complete baseline data and surgical records;
Underwent LSFA with simultaneous placement of a single implant, grafted exclusively with either DBBM (Bio-Oss®, 0.25-1.0 mm, Geistlich Pharma AG, Wolhusen, Switzerland) or DPBM (THE Graft®, 0.25-1.0 mm, Purgo Biologics, Seoul, Korea);
Available CBCT images obtained preoperatively (T0), immediately postoperatively (T1), and at 6 months postoperatively (T2);
RBH ≤6 mm shown by CBCT at T0 at the edentulous site;
No systemic disease, untreated periapical pathology or active periodontitis;
Provision of written informed consent for the implant surgery by the patient or their legal guardian.

Who cannot join

Uncontrolled systemic diseases or any bone-metabolism diseases;
Pregnancy or lactation;
Head and neck radiation therapy within the past 5 years;
acute and chronic inflammation in the maxillary sinus;
Additional vertical or horizontal bone augmentation procedures besides LSFA;
Use of graft materials other than the specified DBBM or DPBM, or use of composite grafts;
Heavy smoking (≥20 cigarettes/day), alcohol abuse, or history of substance abuse;
Placement of multiple implants in the same grafted site (excluded to avoid within-patient confounding).

Trial locations and contacts

1 site in 1 country.

China1 site

The Affiliated Hospital, School of Stomatology, Zhejiang University., Hangzhou, Zhejiang 310000
Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: Radiographic Assessment of Deproteinized Porcine Versus Bovine Bone Mineral in Sinus Augmentation: A Retrospective Study

Does DPBM show greater graft resorption than DBBM at 6 months postoperatively? Do both materials achieve comparable bone quality and osseointegration outcomes despite differences in resorption rates?

This is a retrospective, single-center cohort study. Participants included 56 patients (56 sinuses) who underwent LSFA with either DPBM (test group, n=28) or DBBM (control group, n=28) and had complete cone-beam CT scans taken preoperatively, immediately postoperatively, and at 6 months post-surgery. Radiographic parameters such as bone height, augmentation volume, and bone texture features were analyzed to evaluate graft stability and new bone formation.

Conditions: Sinus Floor Elevation, Sinus Floor Augmentation
Being tested: Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone Mineral
Keywords: clinical research, Sinus Floor Augmentation, Cone-beam computed tomography, Bone Substitutes, Dental Implants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone MineralProcedure or surgery
Lateral Sinus Floor Augmentation Using Deproteinized Porcine Bone Mineral (DPBM, test) with Simultaneous Implant Placement and 6-Month CBCT Follow-Up

Study groups in NCT07182929
Study group	Role	What they receive
DBBM		Patients in DBBM group receive 0.5g of DBBM (Bio-Oss®, 0.25-1.0 mm, Geistlich Pharma AG Co., Ltd, Wolhusen, Switzerland) during the sinus augmentation Receives: Procedure: Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone Mineral
DPBM		Patients in DBBM group receive 0.5g of DBBM (Bio-Oss®, 0.25-1.0 mm, Geistlich Pharma AG Co., Ltd, Wolhusen, Switzerland) during the sinus augmentation

What is being measured

The primary outcome is the main question the study is designed to answer.

Apical Bone Height (ABH)
The vertical distance (mm) from the implant apex to the most apical point of the graft material
Measured: immediately postoperatively (T1), and 6 months postoperatively (T2)
Bone Height (BH)
The vertical distance (mm) from the implant shoulder to the most apical point of the graft material. Site-specific measurements were denoted as buccal (bBH), palatal (pBH), mesial (mBH), and distal (dBH) bone heights
Measured: immediately postoperatively (T1), and 6 months postoperatively (T2)
Endo-Sinus Bone Gain (ESBG)
The vertical distance of the augmented bone along the longitudinal axis of the implant, from the sinus floor to the most apical point of the graft
Measured: immediately postoperatively (T1), and 6 months postoperatively (T2)
augmented volume (AV, mm³)
The augmented volume (AV, mm³) was measured at both T1 and T2 and was analyzed with the segmentation function of 3D Slicer 5.8.1
Measured: immediately postoperatively (T1), and 6 months postoperatively (T2)

Secondary outcomes (1)

Peri-Implant Bone Level (PBL)
The distance (mm) between the most coronal and the most apical levels of the implant-bone/graft contact interface. Site-specific measurements were denoted as buccal (bPBL), palatal (pPBL), mesial (mPBL), and distal (dPBL) peri-implant bone levels
Measured: immediately postoperatively (T1), and 6 months postoperatively (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20241 Jul 2025

First posted19 Sep 2025
Study start1 Jan 2024
Primary completion31 Dec 2024
Study completion1 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Sinus Floor ElevationStudies 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07182929
Sponsor's protocol ID: 2024-153(R)
Other IDs: 81901051, 82370991, 2022KY872
Status last verified: Sep 2025
First submitted: 13 Sep 2025
Last updated: 24 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be shared due to the retrospective nature of the study and ethical considerations related to patient privacy.

Publications

Krennmair S, Postl L, Schwarze UY, Malek M, Stimmelmayr M, Krennmair G. Clinical, radiographic, and histological/histomorphometric analysis of maxillary sinus grafting with deproteinized porcine or bovine bone mineral: A randomized clinical trial. Clin Oral Implants Res. 2023 Nov;34(11):1230-1247. doi: 10.1111/clr.14164. Epub 2023 Aug 23.
PubMed 37610063
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 35224778
Lee JS, Shin HK, Yun JH, Cho KS. Randomized Clinical Trial of Maxillary Sinus Grafting using Deproteinized Porcine and Bovine Bone Mineral. Clin Implant Dent Relat Res. 2017 Feb;19(1):140-150. doi: 10.1111/cid.12430. Epub 2016 Jun 21.
PubMed 27324175
Cassetta M, Perrotti V, Calasso S, Piattelli A, Sinjari B, Iezzi G. Bone formation in sinus augmentation procedures using autologous bone, porcine bone, and a 50 : 50 mixture: a human clinical and histological evaluation at 2 months. Clin Oral Implants Res. 2015 Oct;26(10):1180-4. doi: 10.1111/clr.12423. Epub 2014 May 26.
PubMed 24861978
Pagliani L, Andersson P, Lanza M, Nappo A, Verrocchi D, Volpe S, Sennerby L. A collagenated porcine bone substitute for augmentation at Neoss implant sites: a prospective 1-year multicenter case series study with histology. Clin Implant Dent Relat Res. 2012 Oct;14(5):746-58. doi: 10.1111/j.1708-8208.2010.00314.x. Epub 2010 Oct 26.
PubMed 20977615
Barone A, Ricci M, Covani U, Nannmark U, Azarmehr I, Calvo-Guirado JL. Maxillary sinus augmentation using prehydrated corticocancellous porcine bone: hystomorphometric evaluation after 6 months. Clin Implant Dent Relat Res. 2012 Jun;14(3):373-9. doi: 10.1111/j.1708-8208.2010.00274.x. Epub 2010 May 11.
PubMed 20491813
Iezzi G, Degidi M, Piattelli A, Mangano C, Scarano A, Shibli JA, Perrotti V. Comparative histological results of different biomaterials used in sinus augmentation procedures: a human study at 6 months. Clin Oral Implants Res. 2012 Dec;23(12):1369-76. doi: 10.1111/j.1600-0501.2011.02308.x. Epub 2011 Nov 2.
PubMed 22092377
Scarano A, Piattelli A, Perrotti V, Manzon L, Iezzi G. Maxillary sinus augmentation in humans using cortical porcine bone: a histological and histomorphometrical evaluation after 4 and 6 months. Clin Implant Dent Relat Res. 2011 Mar;13(1):13-8. doi: 10.1111/j.1708-8208.2009.00176.x.
PubMed 19438954
Orsini G, Scarano A, Piattelli M, Piccirilli M, Caputi S, Piattelli A. Histologic and ultrastructural analysis of regenerated bone in maxillary sinus augmentation using a porcine bone-derived biomaterial. J Periodontol. 2006 Dec;77(12):1984-90. doi: 10.1902/jop.2006.060181.
PubMed 17209782

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical, Radiographic, Histological, and Patient-reported/ Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification(OD) Versus Osteotomes (OT) in Subsinus Bone Height of 4-5 mm: An RCT
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All Sinus Floor Elevation trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Radiographic Assessment of Deproteinized Porcine Versus Bovine Bone Mineral in Sinus Augmentation: A Retrospective Study
ClinicalTrials.gov ID: NCT07182929
Acronym / sponsor ID: 2024-153(R)
Conditions: Sinus Floor Elevation, Sinus Floor Augmentation
Keywords: clinical research, Sinus Floor Augmentation, Cone-beam computed tomography, Bone Substitutes, Dental Implants
Study type: Observational
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Guoli YangUniversity, hospital or other
Collaborators: The Dental Hospital of Zhejiang University School of Medicine, National Natural Science Foundation of China
Study start: 1 Jan 2024 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 1 Jul 2025 (actual)
First posted: 19 Sep 2025 (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.

Does DPBM show greater graft resorption than DBBM at 6 months postoperatively? Do both materials achieve comparable bone quality and osseointegration outcomes despite differences in resorption rates?

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
DBBM	–	Procedure: Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone MineralPatients in DBBM group receive 0.5g of DBBM (Bio-Oss®, 0.25-1.0 mm, Geistlich Pharma AG Co., Ltd, Wolhusen, Switzerland) during the sinus augmentation
DPBM	–	–Patients in DBBM group receive 0.5g of DBBM (Bio-Oss®, 0.25-1.0 mm, Geistlich Pharma AG Co., Ltd, Wolhusen, Switzerland) during the sinus augmentation

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who received LSFA with simultaneous implant placement from June 2022 to June 2024 at the Stomatology Hospital, Zhejiang University School of Medicine, were screened for eligibility. All patients underwent preoperative clinical, radiographic examinations and laboratory tests. Eligible patients subsequently received LSFA performed by experienced implant surgeons following the standardized surgical protocol.

Key inclusion criteria (8 listed)

Aged between 18 and 80 years;
Single or multiple missing teeth in the posterior maxilla with a healing period of at least 3 months;
Complete baseline data and surgical records;
Underwent LSFA with simultaneous placement of a single implant, grafted exclusively with either DBBM (Bio-Oss®, 0.25-1.0 mm, Geistlich Pharma AG, Wolhusen, Switzerland) or DPBM (THE Graft®, 0.25-1.0 mm, Purgo Biologics, Seoul, Korea);
Available CBCT images obtained preoperatively (T0), immediately postoperatively (T1), and at 6 months postoperatively (T2);

Key exclusion criteria (8 listed)

Uncontrolled systemic diseases or any bone-metabolism diseases;
Pregnancy or lactation;
Head and neck radiation therapy within the past 5 years;
acute and chronic inflammation in the maxillary sinus;
Additional vertical or horizontal bone augmentation procedures besides LSFA;

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
Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone MineralLateral Sinus Floor Augmentation Using Deproteinized Porcine Bone Mineral (DPBM, test) with Simultaneous Implant Placement and 6-Month CBCT Follow-Up	Procedure or surgery	DBBM

Primary outcome

Apical Bone Height (ABH)
Time frame: immediately postoperatively (T1), and 6 months postoperatively (T2)
The vertical distance (mm) from the implant apex to the most apical point of the graft material
Bone Height (BH)
Time frame: immediately postoperatively (T1), and 6 months postoperatively (T2)
The vertical distance (mm) from the implant shoulder to the most apical point of the graft material. Site-specific measurements were denoted as buccal (bBH), palatal (pBH), mesial (mBH), and distal (dBH) bone heights
Endo-Sinus Bone Gain (ESBG)
Time frame: immediately postoperatively (T1), and 6 months postoperatively (T2)
The vertical distance of the augmented bone along the longitudinal axis of the implant, from the sinus floor to the most apical point of the graft
augmented volume (AV, mm³)
Time frame: immediately postoperatively (T1), and 6 months postoperatively (T2)
The augmented volume (AV, mm³) was measured at both T1 and T2 and was analyzed with the segmentation function of 3D Slicer 5.8.1

1 secondary outcome

Peri-Implant Bone Level (PBL)
Time frame: immediately postoperatively (T1), and 6 months postoperatively (T2)

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 24 Sep 2025.
Background: PubMed 37610063Krennmair S, Postl L, Schwarze UY, Malek M, Stimmelmayr M, Krennmair G. Clinical, radiographic, and histological/histomorphometric analysis of maxillary sinus grafting with deproteinized porcine or bovine bone mineral: A randomized clinical trial. Clin Oral Implants Res. 2023 Nov;34(11):1230-1247. doi: 10.1111/clr.14164. Epub 2023 Aug 23.
Results publication: 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.
Results publication: PubMed 27324175Lee JS, Shin HK, Yun JH, Cho KS. Randomized Clinical Trial of Maxillary Sinus Grafting using Deproteinized Porcine and Bovine Bone Mineral. Clin Implant Dent Relat Res. 2017 Feb;19(1):140-150. doi: 10.1111/cid.12430. Epub 2016 Jun 21.
Results publication: PubMed 24861978Cassetta M, Perrotti V, Calasso S, Piattelli A, Sinjari B, Iezzi G. Bone formation in sinus augmentation procedures using autologous bone, porcine bone, and a 50 : 50 mixture: a human clinical and histological evaluation at 2 months. Clin Oral Implants Res. 2015 Oct;26(10):1180-4. doi: 10.1111/clr.12423. Epub 2014 May 26.
Results publication: PubMed 20977615Pagliani L, Andersson P, Lanza M, Nappo A, Verrocchi D, Volpe S, Sennerby L. A collagenated porcine bone substitute for augmentation at Neoss implant sites: a prospective 1-year multicenter case series study with histology. Clin Implant Dent Relat Res. 2012 Oct;14(5):746-58. doi: 10.1111/j.1708-8208.2010.00314.x. Epub 2010 Oct 26.
Results publication: PubMed 20491813Barone A, Ricci M, Covani U, Nannmark U, Azarmehr I, Calvo-Guirado JL. Maxillary sinus augmentation using prehydrated corticocancellous porcine bone: hystomorphometric evaluation after 6 months. Clin Implant Dent Relat Res. 2012 Jun;14(3):373-9. doi: 10.1111/j.1708-8208.2010.00274.x. Epub 2010 May 11.
Results publication: PubMed 22092377Iezzi G, Degidi M, Piattelli A, Mangano C, Scarano A, Shibli JA, Perrotti V. Comparative histological results of different biomaterials used in sinus augmentation procedures: a human study at 6 months. Clin Oral Implants Res. 2012 Dec;23(12):1369-76. doi: 10.1111/j.1600-0501.2011.02308.x. Epub 2011 Nov 2.
Results publication: PubMed 19438954Scarano A, Piattelli A, Perrotti V, Manzon L, Iezzi G. Maxillary sinus augmentation in humans using cortical porcine bone: a histological and histomorphometrical evaluation after 4 and 6 months. Clin Implant Dent Relat Res. 2011 Mar;13(1):13-8. doi: 10.1111/j.1708-8208.2009.00176.x.
Results publication: PubMed 17209782Orsini G, Scarano A, Piattelli M, Piccirilli M, Caputi S, Piattelli A. Histologic and ultrastructural analysis of regenerated bone in maxillary sinus augmentation using a porcine bone-derived biomaterial. J Periodontol. 2006 Dec;77(12):1984-90. doi: 10.1902/jop.2006.060181.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the retrospective nature of the study and ethical considerations related to patient privacy.

Related trials for Sinus Floor Elevation

Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Recruiting
Using Chin Bone Rings for Sinus Lifting and Dental Implants in One Surgery
Maxillary Deficiency, Bone Resorption
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Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
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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?

An observational study of Sinus Floor Elevation and Sinus Floor Augmentation, run by Guoli Yang at 1 site in China.

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 8 inclusion and 8 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 24 Sep 2025. 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 China. 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?

Apical Bone Height (ABH) (time frame: immediately postoperatively (T1), and 6 months postoperatively (T2)). The study lists 4 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 NCT07182929, which also lists 9 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 24 Sep 2025.