Maxillary Sinus AugmentationNCT05577520
Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles
A study testing Sinus floor augmentation in people with Maxillary Sinus Augmentation, run by Universidad del Salvador, Argentina at 1 site in Argentina.
Trial summary
The decrease in maxillary alveolar ridge bone volume and sinus pneumatization are a challenge to implant-assisted prosthetic rehabilitation. Guided bone regeneration using bone substitutes is an adequate alternative for maxillary sinus augmentation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Maxillary Sinus Augmentation
- What is being tested?
- Sinus floor augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Mar 2016to 30 Aug 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients over the age of 21 years
- Patients missing teeth in the maxillary sinus region (uni- or bilaterally) with a residual subantral bone height ≤ 4 mm and an alveolar ridge width ≥ 6mm.
- Patients who had not undergone tooth extraction within 6 months prior to enrollment.
Who cannot join
- Patients with diabetes, blood discrasias, a history of head and neck chemotherapy/radiation therapy, acute sinusitis or a history of allergic sinusitis, chronic polypoid sinusitis, or sinus tumors, or a history of Caldwell-Luc surgery
- Women who were pregnant or of childbearing age
- Alcoholics and drug abusers
- Patients requiring MS treatment showing anatomical features of the MS that contraindicated the surgical treatment
- Patients who refused to sign the informed consent form
- Patients with a history of chronic periodontitis were treated and then enrolled in the study. Patients who developed post-operative maxillary sinus infection or showed allergic reactions attributable to the grafting material were eliminated from the study.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association
Buenos Aires, 1125
About this study
Official title: Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles: a Histomorfometric Comparison
The decrease in maxillary alveolar ridge bone volume and sinus pneumatization are a challenge to implant-assisted prosthetic rehabilitation. Guided bone regeneration using bone substitutes is an adequate alternative for maxillary sinus augmentation. Objective: To histologically and histomorphometrically compare bone repair response to 250 to 1000 µm and 1000 to 2000 µm anorganic bovine bone mineral (ABBM) particles as bone substitute in maxillary sinus augmentation (MSA).
Read the detailed description
Twenty patients were treated with SMA in two steps. They were randomly assigned to one of two groups (n=10): SPG (small particles group) and LPG (large particles group). Different size ABBM particles were implanted in their maxillary sinus, accordingly. A vertical bone core biopsy was obtained at the implant site using a punch trephine. The samples were processed for histological observation and measured histomorphometrically to determine the percentage onewly formed bone (%NB), bone substitute (%BS), bone marrow (%BM), and osseointegration (%OI). Results were statistically analyzed using Student's t test (p ≤ 0.05).
- Conditions
- Maxillary Sinus Augmentation
- Being tested
- Sinus floor augmentation
- Keywords
- Sinus floor augmentation, Xenograft, Anorganic, Bovine bone, Histomorphometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus floor augmentationProcedure or surgery
Also called Sinus floor lift, Sinus floor elevation
| Study group | Role | What they receive |
|---|---|---|
| Small particle group (SPG) | Experimental | SPG (n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute. Receives: Procedure: Sinus floor augmentation |
| Large particles group (LPG) | Experimental | LPG (n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute. Receives: Procedure: Sinus floor augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of newly formed bone (NB)
histomorphometric parameter was assessed in a standardized area
Measured: 10 month
Percentage of bone substitute
histomorphometric parameter was assessed in a standardized area
Measured: 10 month
Percentage of bone marrow
histomorphometric parameter was assessed in a standardized area
Measured: 10 month
Percentage of osseointegration
histomorphometric parameter was assessed in a standardized area, defined as the percentage of graft particle-newly formed bone integration
Measured: 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Mar 2016
- Primary completion25 Feb 2018
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Maxillary Sinus 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
- Small particle group (SPG n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute. Large particles group (LPG n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Salvador, Argentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Ernesto Aguilar, Universidad del Salvador, Argentina
- Investigators
- jorge aguilar, Chair Prof., Principal investigator, Salvador University /Argentine Dental Association (USAL/AOA)Sandra Renou, Assoc. Prof., Study director, Buenos Aires University (Argentine)Alicia Labandeira, Chair Prof., Principal investigator, Salvador University /Argentine Dental Association (USAL/AOA)Maria Piloni, Assoc. Prof., Principal investigator, Buenos Aires University (Argentine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577520
- Sponsor's protocol ID
- VRDI 1801
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.
PubMed 15626319Smiler DG, Johnson PW, Lozada JL, Misch C, Rosenlicht JL, Tatum OH Jr, Wagner JR. Sinus lift grafts and endosseous implants. Treatment of the atrophic posterior maxilla. Dent Clin North Am. 1992 Jan;36(1):151-86; discussion 187-8.
PubMed 1737600Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol. 2003 Dec;8(1):328-43. doi: 10.1902/annals.2003.8.1.328.
PubMed 14971260Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
PubMed 18724852Cricchio G, Sennerby L, Lundgren S. Sinus bone formation and implant survival after sinus membrane elevation and implant placement: a 1- to 6-year follow-up study. Clin Oral Implants Res. 2011 Oct;22(10):1200-1212. doi: 10.1111/j.1600-0501.2010.02096.x.
PubMed 21906186Bornstein MM, Chappuis V, von Arx T, Buser D. Performance of dental implants after staged sinus floor elevation procedures: 5-year results of a prospective study in partially edentulous patients. Clin Oral Implants Res. 2008 Oct;19(10):1034-43. doi: 10.1111/j.1600-0501.2008.01573.x.
PubMed 18828820Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. No abstract available.
PubMed 6993637Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
PubMed 3516738Pejrone G, Lorenzetti M, Mozzati M, Valente G, Schierano GM. Sinus floor augmentation with autogenous iliac bone block grafts: a histological and histomorphometrical report on the two-step surgical technique. Int J Oral Maxillofac Surg. 2002 Aug;31(4):383-8. doi: 10.1054/ijom.2002.0286.
PubMed 12361071van den Bergh JP, ten Bruggenkate CM, Krekeler G, Tuinzing DB. Sinusfloor elevation and grafting with autogenous iliac crest bone. Clin Oral Implants Res. 1998 Dec;9(6):429-35. doi: 10.1034/j.1600-0501.1996.090608.x.
PubMed 11429944Chackartchi T, Iezzi G, Goldstein M, Klinger A, Soskolne A, Piattelli A, Shapira L. Sinus floor augmentation using large (1-2 mm) or small (0.25-1 mm) bovine bone mineral particles: a prospective, intra-individual controlled clinical, micro-computerized tomography and histomorphometric study. Clin Oral Implants Res. 2011 May;22(5):473-80. doi: 10.1111/j.1600-0501.2010.02032.x. Epub 2010 Nov 19.
PubMed 21087317Pebé PJ, Ramos A, Beovide AV, Borgia G, Ravecca T. Ensayo clínico aleatorizado de elevación sinusal por abordaje lateral con hueso mineral bovino desproteinizado (hmbd) comparando dos tamaños de partículas: resultados clínicos e histológicos. Odontoestomatología. 2017;19:57-67.
de Molon RS, Magalhaes-Tunes FS, Semedo CV, Furlan RG, de Souza LGL, de Souza Faloni AP, Marcantonio E Jr, Faeda RS. A randomized clinical trial evaluating maxillary sinus augmentation with different particle sizes of demineralized bovine bone mineral: histological and immunohistochemical analysis. Int J Oral Maxillofac Surg. 2019 Jun;48(6):810-823. doi: 10.1016/j.ijom.2018.09.003. Epub 2018 Nov 13.
PubMed 30442550Testori T, Wallace SS, Trisi P, Capelli M, Zuffetti F, Del Fabbro M. Effect of xenograft (ABBM) particle size on vital bone formation following maxillary sinus augmentation: a multicenter, randomized, controlled, clinical histomorphometric trial. Int J Periodontics Restorative Dent. 2013 Jul-Aug;33(4):467-75. doi: 10.11607/prd.1423.
PubMed 23820706
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles: a Histomorfometric Comparison
- ClinicalTrials.gov ID
- NCT05577520
- Acronym / sponsor ID
- VRDI 1801
- Conditions
- Maxillary Sinus Augmentation
- Keywords
- Sinus floor augmentation, Xenograft, Anorganic, Bovine bone, Histomorphometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad del Salvador, ArgentinaUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 25 Feb 2018 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 13 Oct 2022 (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 decrease in maxillary alveolar ridge bone volume and sinus pneumatization are a challenge to implant-assisted prosthetic rehabilitation. Guided bone regeneration using bone substitutes is an adequate alternative for maxillary sinus augmentation. Objective: To histologically and histomorphometrically compare bone repair response to 250 to 1000 µm and 1000 to 2000 µm anorganic bovine bone mineral (ABBM) particles as bone substitute in maxillary sinus augmentation (MSA).
Detailed description
Twenty patients were treated with SMA in two steps. They were randomly assigned to one of two groups (n=10): SPG (small particles group) and LPG (large particles group). Different size ABBM particles were implanted in their maxillary sinus, accordingly. A vertical bone core biopsy was obtained at the implant site using a punch trephine. The samples were processed for histological observation and measured histomorphometrically to determine the percentage onewly formed bone (%NB), bone substitute (%BS), bone marrow (%BM), and osseointegration (%OI). Results were statistically analyzed using Student's t test (p ≤ 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Small particle group (SPG n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute. Large particles group (LPG n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.
| Arm | Type | Receives |
|---|---|---|
| Small particle group (SPG) | Experimental | Procedure: Sinus floor augmentationSPG (n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute. |
| Large particles group (LPG) | Experimental | Procedure: Sinus floor augmentationLPG (n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients over the age of 21 years
- Patients missing teeth in the maxillary sinus region (uni- or bilaterally) with a residual subantral bone height ≤ 4 mm and an alveolar ridge width ≥ 6mm.
- Patients who had not undergone tooth extraction within 6 months prior to enrollment.
Key exclusion criteria (6 listed)
- Patients with diabetes, blood discrasias, a history of head and neck chemotherapy/radiation therapy, acute sinusitis or a history of allergic sinusitis, chronic polypoid sinusitis, or sinus tumors, or a history of Caldwell-Luc surgery
- Women who were pregnant or of childbearing age
- Alcoholics and drug abusers
- Patients requiring MS treatment showing anatomical features of the MS that contraindicated the surgical treatment
- Patients who refused to sign the informed consent form
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 |
|---|---|---|
| Sinus floor augmentationAlso: Sinus floor lift, Sinus floor elevation | Procedure or surgery | Large particles group (LPG), Small particle group (SPG) |
Primary outcome
Percentage of newly formed bone (NB)
Time frame: 10 month
histomorphometric parameter was assessed in a standardized area
Percentage of bone substitute
Time frame: 10 month
histomorphometric parameter was assessed in a standardized area
Percentage of bone marrow
Time frame: 10 month
histomorphometric parameter was assessed in a standardized area
Percentage of osseointegration
Time frame: 10 month
histomorphometric parameter was assessed in a standardized area, defined as the percentage of graft particle-newly formed bone integration
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 13 Oct 2022.
- Background: PubMed 15626319Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.
- Results publication: PubMed 1737600Smiler DG, Johnson PW, Lozada JL, Misch C, Rosenlicht JL, Tatum OH Jr, Wagner JR. Sinus lift grafts and endosseous implants. Treatment of the atrophic posterior maxilla. Dent Clin North Am. 1992 Jan;36(1):151-86; discussion 187-8.
- Results publication: PubMed 14971260Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol. 2003 Dec;8(1):328-43. doi: 10.1902/annals.2003.8.1.328.
- Results publication: PubMed 18724852Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
- Results publication: PubMed 21906186Cricchio G, Sennerby L, Lundgren S. Sinus bone formation and implant survival after sinus membrane elevation and implant placement: a 1- to 6-year follow-up study. Clin Oral Implants Res. 2011 Oct;22(10):1200-1212. doi: 10.1111/j.1600-0501.2010.02096.x.
- Results publication: PubMed 18828820Bornstein MM, Chappuis V, von Arx T, Buser D. Performance of dental implants after staged sinus floor elevation procedures: 5-year results of a prospective study in partially edentulous patients. Clin Oral Implants Res. 2008 Oct;19(10):1034-43. doi: 10.1111/j.1600-0501.2008.01573.x.
- Results publication: PubMed 6993637Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. No abstract available.
- Results publication: PubMed 3516738Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
- Results publication: PubMed 12361071Pejrone G, Lorenzetti M, Mozzati M, Valente G, Schierano GM. Sinus floor augmentation with autogenous iliac bone block grafts: a histological and histomorphometrical report on the two-step surgical technique. Int J Oral Maxillofac Surg. 2002 Aug;31(4):383-8. doi: 10.1054/ijom.2002.0286.
- Results publication: PubMed 11429944van den Bergh JP, ten Bruggenkate CM, Krekeler G, Tuinzing DB. Sinusfloor elevation and grafting with autogenous iliac crest bone. Clin Oral Implants Res. 1998 Dec;9(6):429-35. doi: 10.1034/j.1600-0501.1996.090608.x.
- Results publication: PubMed 21087317Chackartchi T, Iezzi G, Goldstein M, Klinger A, Soskolne A, Piattelli A, Shapira L. Sinus floor augmentation using large (1-2 mm) or small (0.25-1 mm) bovine bone mineral particles: a prospective, intra-individual controlled clinical, micro-computerized tomography and histomorphometric study. Clin Oral Implants Res. 2011 May;22(5):473-80. doi: 10.1111/j.1600-0501.2010.02032.x. Epub 2010 Nov 19.
- Results publicationPebé PJ, Ramos A, Beovide AV, Borgia G, Ravecca T. Ensayo clínico aleatorizado de elevación sinusal por abordaje lateral con hueso mineral bovino desproteinizado (hmbd) comparando dos tamaños de partículas: resultados clínicos e histológicos. Odontoestomatología. 2017;19:57-67.
- 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.
jorge aguilar, Chair Prof. principal investigator
Salvador University /Argentine Dental Association (USAL/AOA)
Sandra Renou, Assoc. Prof. study director
Buenos Aires University (Argentine)
Alicia Labandeira, Chair Prof. principal investigator
Salvador University /Argentine Dental Association (USAL/AOA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinus floor augmentation in people with Maxillary Sinus Augmentation, run by Universidad del Salvador, Argentina at 1 site in Argentina.
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 6 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 13 Oct 2022. 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 Argentina. 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?
Percentage of newly formed bone (NB) (time frame: 10 month). 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 NCT05577520, which also lists 14 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 13 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.