Dental Implant Placement in Adjunction With Autologous Alveolar Bone-Marrow Derived Mesenchymal Stem Cells (aBM-MSCs) (Implant_bone)
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|ClinicalTrials.gov Identifier: NCT03070275|
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : November 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Implant Therapy||Biological: Biocomplex: aBM-MSCs/fibrin glue/collagen fleece Procedure: Two-stage surgical implant placement||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, randomised, single blind, control clinical trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcome assessor is not aware of the treatment modality|
|Official Title:||Preservation of Alveolar Crestal Bone From Implant Placement to Implant Exposure Using Autologous Alveolar Bone-Marrow Derived Mesenchymal Stem Cells (aBM-MSCs)|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||December 2017|
In the experimental Group (Group-A), a two-stage implant will be placed in parallel with an overlying biocomplex (aBM-MSCs/fibrin glue/collagen fleece) that comprises autologous alveolar bone marrow mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with autologous fibrin glue.
Biological: Biocomplex: aBM-MSCs/fibrin glue/collagen fleece
Xeno-free, clinical-grade, autologous alveolar bone marrow mesenchymal stem cells enriched with autologous fibrin glue and loaded into a commercially available collagen fleece.
Active Comparator: Control Group-B
In Group-B, a two-stage surgical implant placement on the alveolar crest is followed based on the manufacturer's guidelines with no use of adjunctive grafting materials.
Procedure: Two-stage surgical implant placement
Implants are surgically placed on the alveolar crest following a two-stage protocol and the manufacture's guidelines with no adjunctives.
- A reduction in the marginal bone levels [ Time Frame: baseline (implant placement) to 4 months (implant exposure) ]Intra-surgical clinical data: Changes in the vertical distance from the implant shoulder to the alveolar crest in mm
- Radiographic changes in the marginal bone levels [ Time Frame: baseline (implant placement) to 4 months (implant exposure) ]Radiographic data: linear measurements (mm) on standardised x-rays regarding vertical changes in the marginal bone levels from implant shoulder to the alveolar crest
- Reduction in the thickness of the buccal/lingual bone [ Time Frame: baseline (implant placement) to 4 months (implant exposure) ]Clinical data: Changes in the thickness of the bone plates in the buccal/lingual aspects of the implant
- Changes in the alveolar mucosa [ Time Frame: baseline (implant placement) to 4 months (implant exposure) ]Changes in the thickness of mucosa at the top of the alveolar ridge and at 2- and 4mm apically of the implant shoulder
- Changes in the width of keratised mucosa [ Time Frame: baseline (implant placement) to 4 months (implant exposure) ]Changes in the width of keratinised mucosa in mm at the surgical site
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070275
|Study Chair:||Antonis Konstantinidis, Professor||Retired, Dept. of Preventive Dentistry, Periodontology and Implant Biology, School of Dentistry, Aristotle University of Thessaloniki|