Microarchitecture of the Augmented Bone Following Sinus Elevation (MAB)
Primary Purpose
Alveolar Bone Loss, Sinus Pneumatization, Edentulous; Alveolar Process, Atrophy
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
sinus floor elevation
bone core biopsy
dental implant placement
Cone Beam Computed Tomography scans (CBCT)
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss focused on measuring cone beam computed tomography (CBCT), microcomputed tomography (micro-CT), histomorphometry, sinus floor elevation, allograft, xenograft
Eligibility Criteria
Inclusion Criteria:
- Periodontally healthy patients
- Edentulous posterior maxilla
Exclusion Criteria:
- History of systemic diseases, that alter bone metabolism (osteoporosis, diabetes mellitus),
- History of medication known to alter bone remodelling (bisphosphonates, RANK ligand inhibitor monoclonal antibodies, corticosteroids),
- History of uncontrolled medical or psychiatric disorders,
- Inflammations of the paranasal sinuses or the alveolar process,
- History of tumours or irradiation therapy in the head and neck region,
- Unwillingness to return for follow-ups,
- Pregnancy,
- Smoking,
- Inability to preform proper oral hygiene.
Sites / Locations
- Semmelweis University Department of Community Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
allograft
xenograft
Arm Description
The filler used in sinus floor elevation is albumin impregnated allograft.
The filler used in sinus floor elevation is anorganic bovine bone mineral.
Outcomes
Primary Outcome Measures
newly formed bone percentage
newly formed bone area compared to total area in histomorphometry
BV/TV bone volume fraction
bone volume compared to total volume in micro-CT reconstruction
Secondary Outcome Measures
bone gain
volume of augmented bone on CBCTs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04136509
Brief Title
Microarchitecture of the Augmented Bone Following Sinus Elevation
Acronym
MAB
Official Title
Biomaterials in the Surgical Rehabilitation of Oral and Maxillofacial Hard and Soft Tissue Defects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this prospective randomized clinical study sinus floor elevation procedures are preformed using different biomaterials with the lateral window technique. After a 6-month healing, at the time of dental implant placement bone core biopsy samples are harvested. The samples undergo micro-Ct and histomorphometric analysis.
Detailed Description
Aim of the study The aim of this prospective randomized study is to evaluate the remodeling capacity of albumin impregnated freeze-dried bone allograft in sinus floor augmentation by histomorphometry and micro-CT analysis and to compare it to anorganic bovine xenograft material.
Surgical methods Patients performed oral rinse with 0.2% chlorhexidine solution for 1 min before surgery. Under local anesthesia a full thickness flap was raised from a midcrestal incision along with two relieving incisions. Lateral window osteotomies were carried out with diamond burs. The Schneiderian membrane was carefully elevated. Bone graft material was packed in the defect with light force. Patients were randomly assigned to 2 groups based on the type of bone filler: albumin impregnated allograft (BoneAlbumin, OrthoSera GmbH, Krems an der Donau, Austria) or anorganic bovine bone mineral (ABBM), (Bio-Oss Geistlich Wolhusen, Switzerland). A porcine collagen membrane (Bio Gide, Geistlich GmbH, Wolhusen, Switzerland) was placed over the lateral window and fixed by titanium pins (Titan Pin Set, Ustomed Instruments Ulrich Storz GmbH & Co. KG, Tuttlingen, Germany). The buccal flap was mobilized to allow tension-free primary closure. The margins were stabilized with single interrupted sutures. Antibiotics (1 g amoxicillin-clavulanate twice a day for 5 days, or in case of side effects or known allergy to penicillin, 300 mg clindamycin 4 times a day for 4 days), anti-inflammatory drugs (50 mg diclofenac 3 times a day for 3 days), and chlorhexidine mouthwash (twice a day for 21 days from the first day after surgery) were prescribed. Sutures were removed after 10 days. After 6 months healing surgical re-entry procedure took place under local anesthesia. A bone core biopsy was taken with a trephine with an external diameter of 3.5 mm and an internal diameter of 2.5 mm (330 205 486 001 025 Hager & Meisinger GmbH, Neuss, Germany) and implants of at least 4.0 mm of diameter were placed into the grafted alveolus nonsubmerged.
Histomorphometry Bone core biopsy material was fixed in 10% buffered formaldehyde solution. Following decalcination and dehydration, the biopsy material was embedded in paraffin and 20 µm sections were prepared. The sections were stained with routine haematoxylin eosin stain. Sections were evaluated under a light microscope in magnification 40×-400× .
Histomorphometric measurements were completed on sections with Panoramic Viewer 1.15 (3DHISTECH Ltd., Budapest, Hungary) using a combination of Adobe PhotoShop (Adobe System Inc., San Jose, CA, USA) and ImageJ, the public domain NIH Image program (US National Institutes of Health' http://rsb.info.nih.gov/nih-image/) at 150× magnification. Two slides of the augmented areas in each bone core biopsy sample were evaluated to record area percentage of newly formed bone, residual particles of the bone graft material, and the bone marrow space according to published protocols. Histomorphometric data consisted of the area percentage of newly formed bone, residual particles of the graft material and bone marrow were identified in each section.
Micro-CT analysis The bone core biopsy samples were scanned using a microcomputed tomography (μCT) scanner (Skyscan 1172 X-ray microtomograph, Bruker µCT, Kontich, Belgium). After the acquisition, raw images were reconstructed using NRecon software (v.1.7.1.6., Bruker µCT, Kontich, Belgium). The morphometric variables relevant to our study calculated by CTAn software (v.1.17.7.2, Bruker µCT, Kontich, Belgium). On the reconstructed images of each sample the demarcation plane of the host and the augmented area was identified and the complete available tissue (maxilla or augmented bone, respectively) were selected as regions of interest (ROIs) for quantitative analysis.
Micromorphometric data was collected by evaluation of the augmented bone of the test or control group. Additional micromorphometric data was recorded by analyzing the native bone of the alveolar ridge within the bone core biopsy samples of both test and control group. The microarchitectural parameters of the augmented bone of the BoneAlbumin group and the ABBM group; the augmented bone of the BoneAlbumin group and the native bone of the alveolar ridge; the augmented bone of the ABBM group and the native bone of the alveolar ridge were compared.
Statistical analysis Percentage values of each bone core biopsy sample were used to calculate descriptive statistics for the histomorphometrical and quantitative µCT analysis. The results were analyzed statistically using the IBM SPSS Statistics 23 data analysis software program (IBM Corporation, New York, NY. USA). The Kruskal Wallis One-way ANOVA test was used to compare two sets of data for the statistical analysis of the histomorphometric results. One-way ANOVA test was used to compare three sets of data for the statistical analysis of the micromorphometric results of the micro-CT. Values of p < 0.05 were considered statistically significant.
CBCT CBCT imaging (PaX-Reve3D, Vatech, Hwaseong, South-Korea) was carried out prior to sinus floor elevation to evaluate the anatomy and possible pathology of the maxillary sinuses, then 6 months after bone augmentation prior to implant placement (preoperative CBCT), and 3 years after implant placement (postoperative CBCT). To register the preoperative and postoperative CBCT data by anatomical landmarks 3DSlicer 4.10.2 software (The Brigham and Women's Hospital, Inc. Boston, USA) was used. The ROIs were identified by determining the central axis of the implants and placing a virtual cylinder on the preoperative CBCT image sequence with a diameter of 2,5 mm and the length of 8 mm on this axis corresponding with the inner dimensions of the trephine used for bone core biopsy harvesting. The image sequences of selected ROIs were imported in CTAn software (v.1.17.7.2, Bruker micro-CT, Kontich, Belgium) and micromorphometric variables were calculated by the software.
Statistical analysis of CBCT results Correlation of the micromorphometric data obtained from the CBCT images and micro-CT images was determined by The Spearman's rank-order correlation. Statistical analysis was performed using the IBM SPSS Statistics 25 data analysis software program (IBM Corporation, New York, USA). Values of P < 0.05 were considered statistically significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Sinus Pneumatization, Edentulous; Alveolar Process, Atrophy
Keywords
cone beam computed tomography (CBCT), microcomputed tomography (micro-CT), histomorphometry, sinus floor elevation, allograft, xenograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The specialis tasked with histomorphometric, micro-CT and CBCT analysis has no knowledge on the intervention method.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
allograft
Arm Type
Experimental
Arm Description
The filler used in sinus floor elevation is albumin impregnated allograft.
Arm Title
xenograft
Arm Type
Experimental
Arm Description
The filler used in sinus floor elevation is anorganic bovine bone mineral.
Intervention Type
Procedure
Intervention Name(s)
sinus floor elevation
Other Intervention Name(s)
maxillary sinus augmentation
Intervention Description
sinus floor elevation with the lateral technique
Intervention Type
Procedure
Intervention Name(s)
bone core biopsy
Intervention Description
After 6 month healing time reentry took place and bone core biopsy samples were collected from the augmented bone of the maxillary sinuses with a trephine drill. Biopsy samples were collected from the sites where the dental implants were to be placed.
Intervention Type
Device
Intervention Name(s)
dental implant placement
Intervention Description
During reentry after bone biopsy dental implants were placed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cone Beam Computed Tomography scans (CBCT)
Intervention Description
Preoperative CBCT scans are carried out before dental implant placement, 6 months after sinus floor elevations. Postoperative CBCT scans are taken 3 years after sinus floor augmentations.
Primary Outcome Measure Information:
Title
newly formed bone percentage
Description
newly formed bone area compared to total area in histomorphometry
Time Frame
6 months
Title
BV/TV bone volume fraction
Description
bone volume compared to total volume in micro-CT reconstruction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
bone gain
Description
volume of augmented bone on CBCTs
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Periodontally healthy patients
Edentulous posterior maxilla
Exclusion Criteria:
History of systemic diseases, that alter bone metabolism (osteoporosis, diabetes mellitus),
History of medication known to alter bone remodelling (bisphosphonates, RANK ligand inhibitor monoclonal antibodies, corticosteroids),
History of uncontrolled medical or psychiatric disorders,
Inflammations of the paranasal sinuses or the alveolar process,
History of tumours or irradiation therapy in the head and neck region,
Unwillingness to return for follow-ups,
Pregnancy,
Smoking,
Inability to preform proper oral hygiene.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
György Szabó, Md PhD Msc
Organizational Affiliation
Department of Oro-Maxillofacial Surgery and Stomatology Semmelweis University
Official's Role
Study Director
Facility Information:
Facility Name
Semmelweis University Department of Community Dentistry
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
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Microarchitecture of the Augmented Bone Following Sinus Elevation
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