search
Back to results

Tomographic and Histologic Assessment on the Influence of the Use of a Collagen Membrane to Protect the Antrostomy After Maxillary Sinus Floor Augmentation.

Primary Purpose

Alveolar Bone Loss, Alveolar Bone Resorption

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Maxillary sinus augmentation
Sponsored by
ARDEC Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring antrostomy, Maxillary sinus augmentation, collagen membrane, biomaterial

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Colombia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

test site

control site

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 23, 2019
Last Updated
January 5, 2022
Sponsor
ARDEC Academy
search

1. Study Identification

Unique Protocol Identification Number
NCT03899688
Brief Title
Tomographic and Histologic Assessment on the Influence of the Use of a Collagen Membrane to Protect the Antrostomy After Maxillary Sinus Floor Augmentation.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2015 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
March 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARDEC Academy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Alveolar Bone Resorption
Keywords
antrostomy, Maxillary sinus augmentation, collagen membrane, biomaterial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
test and control group
Masking
InvestigatorOutcomes Assessor
Masking Description
the surgeon will be blinded until the maxillary sinus augmentation is filled with the biomaterial.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test site
Arm Type
Experimental
Arm Description
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.
Arm Title
control site
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Maxillary sinus augmentation
Other Intervention Name(s)
maxillary sinus lift, maxillary sinus elevation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changing in height of the elevated zone.
Description
will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies
Time Frame
The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
Title
Bone-to-implant contact between the different surfaces and between membrane / no membrane groups
Description
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
Time Frame
three months of healing
Secondary Outcome Measure Information:
Title
Changing in area of the elevated zone
Description
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.
Time Frame
The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
Title
Bone density
Description
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.
Time Frame
three months of healing

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Gender identity
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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.
Facility Information:
Facility Name
Colombia
City
Cartagena de Indias
State/Province
Cartagena
ZIP/Postal Code
5710
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18724852
Citation
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.
Results Reference
result
PubMed Identifier
22151577
Citation
Barone 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 Reference
result
PubMed Identifier
30768660
Citation
Masuda 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 Reference
result
PubMed Identifier
15726851
Citation
Lundgren 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 Reference
result
PubMed Identifier
21906186
Citation
Cricchio 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 Reference
result
PubMed Identifier
24445918
Citation
Moon 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 Reference
result
PubMed Identifier
29876969
Citation
Omori 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 Reference
result
PubMed Identifier
26452326
Citation
Corbella 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 Reference
result
PubMed Identifier
27080163
Citation
Caneva 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 Reference
result
PubMed Identifier
26969193
Citation
De 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 Reference
result
PubMed Identifier
22899930
Citation
Riachi 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 Reference
result
PubMed Identifier
25032768
Citation
Shanbhag 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.
Results Reference
result

Learn more about this trial

Tomographic and Histologic Assessment on the Influence of the Use of a Collagen Membrane to Protect the Antrostomy After Maxillary Sinus Floor Augmentation.

We'll reach out to this number within 24 hrs