Alveolar Bone LossNCT03899688
Tomographic and Histologic Assessment on the Influence of the Use of a Collagen Membrane to Protect the Antrostomy After Maxillary Sinus Floor Augmentation.
A study testing Maxillary sinus augmentation in people with Alveolar Bone Loss and Alveolar Bone Resorption, run by ARDEC Academy at 1 site in Colombia.
Trial summary
the aim of the present study was to evaluate the dimensional variation and osseointegration of mini-implants at augmented sinus with the antrostomy left unprotected or protected with a collagen membrane. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Alveolar Bone Resorption
- What is being tested?
- Maxillary sinus 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 siteColombia
- Study dates
- 20 Feb 2015to 2 Mar 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of an edentulous atrophic zone in the posterior segment of the maxilla
- Height of the sinus floor ≤4 mm.
- Desiring a prosthetic restoration of the zone using a fix prosthesis supported by implants
- ≥ 21 years of age
- Good general health
- No contraindication for oral surgical procedures
Show all 13Show fewer
- Not being pregnant.
- Exclusion Criteria:The patients will be excluded if they present:
- A systemic disordered.
- Had a chemotherapic or radiotherapeutic treatment.
- Are smokers >10 cigarettes per day
- Have an acute or a chronic sinusitis.
- Had a previous bone augmentation procedures in the zone of interest.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cone Beam Computed Tomography and Histomorphometric Assessments on the Influence a Collagen Membrane Placed on the Antrostomy After Maxillary Sinus Floor Augmentation. A Randomized Clinical Trial.
the aim of the present study was to evaluate the dimensional variation and osseointegration of mini-implants at augmented sinus with the antrostomy left unprotected or protected with a collagen membrane.
Read the detailed description
The Schneiderian mucosa will be elevated and the created space will be filled with a natural bovine bone grafting material (Cerabone® 1-2 mm, Botiss Biomaterials GmbH). In ten patients randomly selected (control sties), a native collagen membrane made of porcine dermis (Collprotect®, Botiss Biomaterials GmbH) will be placed on the antrostomy. In another ten patients of the test group, the antrostomy will be left without the membrane. The flaps will be sutured and anti-inflammatory drugs and antibiotics will be administrated to the patients. The sutures will be removed after 7 days. After 6 months of healing, two mini-implants with different surface will be installed and retrieved after further 3 months for histomorphometric evaluations.
CBCTs will be taken for all patients before surgery (T0), after 1 week from sinus floor augmentation (T1) and after 9 months of healing (T2) and evaluation of dimensional variations over time of soft and hard tissues will be performed.
- Conditions
- Alveolar Bone Loss, Alveolar Bone Resorption
- Being tested
- Maxillary sinus augmentation
- Keywords
- antrostomy, Maxillary sinus augmentation, collagen membrane, biomaterial
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary sinus augmentationProcedure or surgery
Also called maxillary sinus lift, maxillary sinus elevation
Surgical technique for increasing the vertical bone height of the posterior maxilla an antrostomy of about 5 mm in height and 10 mm long will be prepared using a diamond insert mounted on a sonic-air surgical instrument. The Schneiderian membrane will be elevated and clinical measurements will be performed using an UNC 15 probe. The space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites.
| Study group | Role | What they receive |
|---|---|---|
| test site | Experimental | The space obtained underneath the sinus mucosa will be filled with the xenograft without protecting the antrostomy with a collagen membrane in the test sites. Bone to implant contact was measured at the turned and machined surface. Receives: Procedure: Maxillary sinus augmentation |
| control site | Active comparator | The space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites. Bone to implant contact was measured at the turned and machined surface. Receives: Procedure: Maxillary sinus augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing in height of the elevated zone.
will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies
Measured: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
Bone-to-implant contact between the different surfaces and between membrane / no membrane groups
Measurements of new bone formation will be assessed on the histological images taken from the slides and performed between the most coronal bone contact to the surface and the apex of the mini-implant. Comparisons among test and control (without or with a collagen membrane of the access window) and between the two different surface conformations will be performed
Measured: three months of healing
Secondary outcomes (2)
Changing in area of the elevated zone
The area will be delineated by the sinus bone walls and the sinus mucosa. The changes will be evaluated on the cone beam computerized tomographies (CBCTs) taken in various periods.
Measured: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
Bone density
Measurements of new bone formation will be assessed on the histological images taken from the slides and performed between the most coronal bone contact to the surface and the apex of the mini-implant. Comparisons among test and control (without or with a collagen membrane of the access window) and between the two different surface conformations will be performed.
Measured: three months of healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start20 Feb 2015
- Primary completion21 Dec 2018
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies 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
- test and control group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARDEC Academy
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899688
- Sponsor's protocol ID
- CBCT
- Status last verified
- Jan 2022
- First submitted
- 23 Mar 2019
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pjetursson 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 18724852Barone A, Ricci M, Grassi RF, Nannmark U, Quaranta A, Covani U. A 6-month histological analysis on maxillary sinus augmentation with and without use of collagen membranes over the osteotomy window: randomized clinical trial. Clin Oral Implants Res. 2013 Jan;24(1):1-6. doi: 10.1111/j.1600-0501.2011.02340.x. Epub 2011 Dec 12.
PubMed 22151577Masuda K, Silva ER, Botticelli D, Apaza Alccayhuaman KA, Xavier SP. Antrostomy Preparation for Maxillary Sinus Floor Augmentation Using Drills or a Sonic Instrument: A Microcomputed Tomography and Histomorphometric Study in Rabbits. Int J Oral Maxillofac Implants. 2019 July/August;34(4):819-827. doi: 10.11607/jomi.7350. Epub 2019 Feb 15.
PubMed 30768660Lundgren S, Andersson S, Gualini F, Sennerby L. Bone reformation with sinus membrane elevation: a new surgical technique for maxillary sinus floor augmentation. Clin Implant Dent Relat Res. 2004;6(3):165-73.
PubMed 15726851Cricchio 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 21906186Moon YS, Sohn DS, Moon JW, Lee JH, Park IS, Lee JK. Comparative histomorphometric analysis of maxillary sinus augmentation with absorbable collagen membrane and osteoinductive replaceable bony window in rabbits. Implant Dent. 2014 Feb;23(1):29-36. doi: 10.1097/ID.0000000000000031.
PubMed 24445918Omori Y, Ricardo Silva E, Botticelli D, Apaza Alccayhuaman KA, Lang NP, Xavier SP. Reposition of the bone plate over the antrostomy in maxillary sinus augmentation: A histomorphometric study in rabbits. Clin Oral Implants Res. 2018 Aug;29(8):821-834. doi: 10.1111/clr.13292. Epub 2018 Jun 7.
PubMed 29876969Corbella S, Taschieri S, Weinstein R, Del Fabbro M. Histomorphometric outcomes after lateral sinus floor elevation procedure: a systematic review of the literature and meta-analysis. Clin Oral Implants Res. 2016 Sep;27(9):1106-22. doi: 10.1111/clr.12702. Epub 2015 Oct 10.
PubMed 26452326Caneva M, Lang NP, Garcia Rangel IJ, Ferreira S, Caneva M, De Santis E, Botticelli D. Sinus mucosa elevation using Bio-Oss(R) or Gingistat(R) collagen sponge: an experimental study in rabbits. Clin Oral Implants Res. 2017 Jul;28(7):e21-e30. doi: 10.1111/clr.12850. Epub 2016 Apr 15.
PubMed 27080163De Santis E, Lang NP, Ferreira S, Rangel Garcia I Jr, Caneva M, Botticelli D. Healing at implants installed concurrently to maxillary sinus floor elevation with Bio-Oss(R) or autologous bone grafts. A histo-morphometric study in rabbits. Clin Oral Implants Res. 2017 May;28(5):503-511. doi: 10.1111/clr.12825. Epub 2016 Mar 10.
PubMed 26969193Riachi F, Naaman N, Tabarani C, Aboelsaad N, Aboushelib MN, Berberi A, Salameh Z. Influence of material properties on rate of resorption of two bone graft materials after sinus lift using radiographic assessment. Int J Dent. 2012;2012:737262. doi: 10.1155/2012/737262. Epub 2012 Jul 31.
PubMed 22899930Shanbhag S, Shanbhag V, Stavropoulos A. Volume changes of maxillary sinus augmentations over time: a systematic review. Int J Oral Maxillofac Implants. 2014 Jul-Aug;29(4):881-92. doi: 10.11607/jomi.3472.
PubMed 25032768
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cone Beam Computed Tomography and Histomorphometric Assessments on the Influence a Collagen Membrane Placed on the Antrostomy After Maxillary Sinus Floor Augmentation. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03899688
- Acronym / sponsor ID
- CBCT
- Conditions
- Alveolar Bone Loss, Alveolar Bone Resorption
- Keywords
- antrostomy, Maxillary sinus augmentation, collagen membrane, biomaterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ARDEC AcademyResearch network
- Study start
- 20 Feb 2015 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 2 Apr 2019 (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 aim of the present study was to evaluate the dimensional variation and osseointegration of mini-implants at augmented sinus with the antrostomy left unprotected or protected with a collagen membrane.
Detailed description
The Schneiderian mucosa will be elevated and the created space will be filled with a natural bovine bone grafting material (Cerabone® 1-2 mm, Botiss Biomaterials GmbH). In ten patients randomly selected (control sties), a native collagen membrane made of porcine dermis (Collprotect®, Botiss Biomaterials GmbH) will be placed on the antrostomy. In another ten patients of the test group, the antrostomy will be left without the membrane. The flaps will be sutured and anti-inflammatory drugs and antibiotics will be administrated to the patients. The sutures will be removed after 7 days. After 6 months of healing, two mini-implants with different surface will be installed and retrieved after further 3 months for histomorphometric evaluations.
CBCTs will be taken for all patients before surgery (T0), after 1 week from sinus floor augmentation (T1) and after 9 months of healing (T2) and evaluation of dimensional variations over time of soft and hard tissues will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- test and control group
| Arm | Type | Receives |
|---|---|---|
| test site | Experimental | Procedure: Maxillary sinus augmentationThe space obtained underneath the sinus mucosa will be filled with the xenograft without protecting the antrostomy with a collagen membrane in the test sites. Bone to implant contact was measured at the turned and machined surface. |
| control site | Active comparator | Procedure: Maxillary sinus augmentationThe space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites. Bone to implant contact was measured at the turned and machined surface. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Presence of an edentulous atrophic zone in the posterior segment of the maxilla
- Height of the sinus floor ≤4 mm.
- Desiring a prosthetic restoration of the zone using a fix prosthesis supported by implants
- ≥ 21 years of age
- Good general health
Key exclusion criteria (0 listed)
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 augmentationAlso: maxillary sinus lift, maxillary sinus elevationSurgical technique for increasing the vertical bone height of the posterior maxilla an antrostomy of about 5 mm in height and 10 mm long will be prepared using a diamond insert mounted on a sonic-air surgical instrument. The Schneiderian membrane will be elevated and clinical measurements will be performed using an UNC 15 probe. The space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites. | Procedure or surgery | control site, test site |
Primary outcome
Changing in height of the elevated zone.
Time frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies
Bone-to-implant contact between the different surfaces and between membrane / no membrane groups
Time frame: three months of healing
Measurements of new bone formation will be assessed on the histological images taken from the slides and performed between the most coronal bone contact to the surface and the apex of the mini-implant. Comparisons among test and control (without or with a collagen membrane of the access window) and between the two different surface conformations will be performed
2 secondary outcomes
Changing in area of the elevated zone
Time frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
Bone density
Time frame: three months of healing
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 20 Jan 2022.
- 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 22151577Barone A, Ricci M, Grassi RF, Nannmark U, Quaranta A, Covani U. A 6-month histological analysis on maxillary sinus augmentation with and without use of collagen membranes over the osteotomy window: randomized clinical trial. Clin Oral Implants Res. 2013 Jan;24(1):1-6. doi: 10.1111/j.1600-0501.2011.02340.x. Epub 2011 Dec 12.
- Results publication: PubMed 30768660Masuda K, Silva ER, Botticelli D, Apaza Alccayhuaman KA, Xavier SP. Antrostomy Preparation for Maxillary Sinus Floor Augmentation Using Drills or a Sonic Instrument: A Microcomputed Tomography and Histomorphometric Study in Rabbits. Int J Oral Maxillofac Implants. 2019 July/August;34(4):819-827. doi: 10.11607/jomi.7350. Epub 2019 Feb 15.
- Results publication: PubMed 15726851Lundgren S, Andersson S, Gualini F, Sennerby L. Bone reformation with sinus membrane elevation: a new surgical technique for maxillary sinus floor augmentation. Clin Implant Dent Relat Res. 2004;6(3):165-73.
- 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 24445918Moon YS, Sohn DS, Moon JW, Lee JH, Park IS, Lee JK. Comparative histomorphometric analysis of maxillary sinus augmentation with absorbable collagen membrane and osteoinductive replaceable bony window in rabbits. Implant Dent. 2014 Feb;23(1):29-36. doi: 10.1097/ID.0000000000000031.
- Results publication: PubMed 29876969Omori Y, Ricardo Silva E, Botticelli D, Apaza Alccayhuaman KA, Lang NP, Xavier SP. Reposition of the bone plate over the antrostomy in maxillary sinus augmentation: A histomorphometric study in rabbits. Clin Oral Implants Res. 2018 Aug;29(8):821-834. doi: 10.1111/clr.13292. Epub 2018 Jun 7.
- Results publication: PubMed 26452326Corbella S, Taschieri S, Weinstein R, Del Fabbro M. Histomorphometric outcomes after lateral sinus floor elevation procedure: a systematic review of the literature and meta-analysis. Clin Oral Implants Res. 2016 Sep;27(9):1106-22. doi: 10.1111/clr.12702. Epub 2015 Oct 10.
- Results publication: PubMed 27080163Caneva M, Lang NP, Garcia Rangel IJ, Ferreira S, Caneva M, De Santis E, Botticelli D. Sinus mucosa elevation using Bio-Oss(R) or Gingistat(R) collagen sponge: an experimental study in rabbits. Clin Oral Implants Res. 2017 Jul;28(7):e21-e30. doi: 10.1111/clr.12850. Epub 2016 Apr 15.
- Results publication: PubMed 26969193De Santis E, Lang NP, Ferreira S, Rangel Garcia I Jr, Caneva M, Botticelli D. Healing at implants installed concurrently to maxillary sinus floor elevation with Bio-Oss(R) or autologous bone grafts. A histo-morphometric study in rabbits. Clin Oral Implants Res. 2017 May;28(5):503-511. doi: 10.1111/clr.12825. Epub 2016 Mar 10.
- Results publication: PubMed 22899930Riachi F, Naaman N, Tabarani C, Aboelsaad N, Aboushelib MN, Berberi A, Salameh Z. Influence of material properties on rate of resorption of two bone graft materials after sinus lift using radiographic assessment. Int J Dent. 2012;2012:737262. doi: 10.1155/2012/737262. Epub 2012 Jul 31.
- Results publication: PubMed 25032768Shanbhag S, Shanbhag V, Stavropoulos A. Volume changes of maxillary sinus augmentations over time: a systematic review. Int J Oral Maxillofac Implants. 2014 Jul-Aug;29(4):881-92. doi: 10.11607/jomi.3472.
- 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.
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 augmentation in people with Alveolar Bone Loss and Alveolar Bone Resorption, run by ARDEC Academy at 1 site in Colombia.
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 13 inclusion and 0 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 20 Jan 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 Colombia. 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?
Changing in height of the elevated zone. (time frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery). The study lists 2 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 NCT03899688, which also lists 12 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 20 Jan 2022.