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Histomorphometric and Tomographic Assessment on the Influence of the Placement of a Collagen Membrane Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation

Primary Purpose

Alveolar Bone Loss

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 maxillary sinus, collagen membrane, CBCT, Histology

Eligibility Criteria

21 Years - undefined (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:

  • 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

Experimental

Arm Label

test site

control site

Arm Description

The sinus mucosa will be elevated and, at the test sites, a collagen membrane will be placed subjacent the sinus mucosa

The sinus mucosa will be elevated and, at the control sites, a collagen membrane will not be placed subjacent the sinus mucosa

Outcomes

Primary Outcome Measures

Changing in height of the elevated zone
Measurements will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies (CBCTs) taken in various periods.
New bone-to-implant contact
Measurements will be assessed between the most coronal (B) and the most apical (A) contacts of new bone to the implant surface.

Secondary Outcome Measures

Changing in mucosa thickness
Measurements will be assessed in the cone beam computerized tomographies (CBCTs) taken in various periods. Comparisons among the CBCTs of each participants will be performed.
New bone density around the mini-implant, from B to A and up to a distance of 400 µm from the implant surface.
Measurements will be assessed using a point counting procedure, superposing a lattice with squares of 50 µm over the histological image.

Full Information

First Posted
March 30, 2019
Last Updated
September 30, 2020
Sponsor
ARDEC Academy
Collaborators
Corporacion Universitaria Rafael Nunez
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1. Study Identification

Unique Protocol Identification Number
NCT03902457
Brief Title
Histomorphometric and Tomographic Assessment on the Influence of the Placement of a Collagen Membrane Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation
Official Title
Histomorphometric and Cone Beam Computed Tomography Assessments on the Influence a Collagen Membrane Placed Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation. A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2016 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARDEC Academy
Collaborators
Corporacion Universitaria Rafael Nunez

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 purpose of the study is to look for differences in dimensional variations of augmented maxillary sinuses with or without the placement of a collagen membrane subjacent the sinus mucosa.
Detailed Description
Material and Methods: After the elevation of the maxillary sinus mucosa, a collagen membrane with standard dimensions will be placed at the test sites subjacent the sinus mucosa and the elevated space will be filled with a xenograft, both test and control groups. A collagen membrane will be placed to cover the antrostomy at both groups and sutures will be provided to close the wound. After six months of healing, mini-implants will be installed. After 9 months, biopsies containing the mini-implants will be harvested for histomorphometric analyses. 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). Osseointegration of the mini-implants and dimensional changes over time of soft and hard tissues will be evaluated on the CBCTs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
maxillary sinus, collagen membrane, CBCT, Histology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical trial
Masking
Care ProviderInvestigator
Masking Description
An author not involved in the surgeries will perform the randomization process. The assignments will be sealed within opaque envelopes that will be opened after the completion of the elevation of the sinus mucosa.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test site
Arm Type
Experimental
Arm Description
The sinus mucosa will be elevated and, at the test sites, a collagen membrane will be placed subjacent the sinus mucosa
Arm Title
control site
Arm Type
Experimental
Arm Description
The sinus mucosa will be elevated and, at the control sites, a collagen membrane will not be placed subjacent the sinus mucosa
Intervention Type
Procedure
Intervention Name(s)
Maxillary sinus augmentation
Other Intervention Name(s)
maxillary sinus lift, maxillary sinus elevation
Intervention Description
Maxillary sinus augmentation procedures have become increasingly popular procedures before placement of dental implants in posterior maxillae that have suffered severe bone loss due to sinus pneumatization, alveolar bone atrophy, or trauma.
Primary Outcome Measure Information:
Title
Changing in height of the elevated zone
Description
Measurements will be assessed in the medial, middle and lateral regions of the elevated zone using 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
New bone-to-implant contact
Description
Measurements will be assessed between the most coronal (B) and the most apical (A) contacts of new bone to the implant surface.
Time Frame
Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing.
Secondary Outcome Measure Information:
Title
Changing in mucosa thickness
Description
Measurements will be assessed in the cone beam computerized tomographies (CBCTs) taken in various periods. Comparisons among the CBCTs of each participants will be performed.
Time Frame
The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.
Title
New bone density around the mini-implant, from B to A and up to a distance of 400 µm from the implant surface.
Description
Measurements will be assessed using a point counting procedure, superposing a lattice with squares of 50 µm over the histological image.
Time Frame
Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 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: 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
Yes
IPD Sharing Plan Description
the results will be published in a Journal
IPD Sharing Time Frame
will be become available after the time required by the journal for publication and will be available all the time the journal is active.
Citations:
PubMed Identifier
15152813
Citation
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Results Reference
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Citation
Nolan PJ, Freeman K, Kraut RA. Correlation between Schneiderian membrane perforation and sinus lift graft outcome: a retrospective evaluation of 359 augmented sinus. J Oral Maxillofac Surg. 2014 Jan;72(1):47-52. doi: 10.1016/j.joms.2013.07.020. Epub 2013 Sep 24.
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Citation
Kawakami S, Lang NP, Iida T, Ferri M, Apaza Alccayhuaman KA, Botticelli D. Influence of the position of the antrostomy in sinus floor elevation assessed with cone-beam computed tomography: A randomized clinical trial. J Investig Clin Dent. 2018 Nov;9(4):e12362. doi: 10.1111/jicd.12362. Epub 2018 Aug 24.
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PubMed Identifier
30521653
Citation
Kawakami S, Lang NP, Ferri M, Apaza Alccayhuaman KA, Botticelli D. Influence of the height of the antrostomy in sinus floor elevation assessed by cone beam computed tomography- a randomized clinical trial. Int J Oral Maxillofac Implants. 2019 January/February;34(1):223-232. doi: 10.11607/jomi.7112. Epub 2018 Dec 5.
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PubMed Identifier
28593727
Citation
Iida T, Carneiro Martins Neto E, Botticelli D, Apaza Alccayhuaman KA, Lang NP, Xavier SP. Influence of a collagen membrane positioned subjacent the sinus mucosa following the elevation of the maxillary sinus. A histomorphometric study in rabbits. Clin Oral Implants Res. 2017 Dec;28(12):1567-1576. doi: 10.1111/clr.13027. Epub 2017 Jun 7.
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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.
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PubMed Identifier
11794569
Citation
Aimetti M, Romagnoli R, Ricci G, Massei G. Maxillary sinus elevation: the effect of macrolacerations and microlacerations of the sinus membrane as determined by endoscopy. Int J Periodontics Restorative Dent. 2001 Dec;21(6):581-9.
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Citation
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Citation
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Citation
Choi BH, Zhu SJ, Jung JH, Lee SH, Huh JY. The use of autologous fibrin glue for closing sinus membrane perforations during sinus lifts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Feb;101(2):150-4. doi: 10.1016/j.tripleo.2005.04.008. Epub 2005 Sep 19.
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PubMed Identifier
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Citation
Pikos MA. Maxillary sinus membrane repair: report of a technique for large perforations. Implant Dent. 1999;8(1):29-34. doi: 10.1097/00008505-199901000-00003.
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PubMed Identifier
18351198
Citation
Testori T, Wallace SS, Del Fabbro M, Taschieri S, Trisi P, Capelli M, Weinstein RL. Repair of large sinus membrane perforations using stabilized collagen barrier membranes: surgical techniques with histologic and radiographic evidence of success. Int J Periodontics Restorative Dent. 2008 Feb;28(1):9-17.
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Results Reference
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Histomorphometric and Tomographic Assessment on the Influence of the Placement of a Collagen Membrane Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation

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