Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dental Implant Placement in Adjunction With Autologous Alveolar Bone-Marrow Derived Mesenchymal Stem Cells (aBM-MSCs) (Implant_bone)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03070275
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Danae A. Apatzidou, Aristotle University Of Thessaloniki

Brief Summary:
Systemically healthy volunteers with no active periodontal disease are recruited from referrals to the Dept. of Preventive Dentistry, Periodontology and Biology of Implants, Aristotle Univ of Thessaloniki for implant therapy. After signing a consent form, participants will be randomized into two treatment groups. Group-A (NA=10) will receive crestal placement of implants following a two-stage protocol in combination with a biocomplex comprising 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. In Group-B (NB=10) implants are placed on the alveolar crest following a two-stage protocol and the manufacturer's guidelines. Intra-surgical clinical and radiographic assessments are performed at the time of implant placement (T0) and at the two-stage surgery (T1). Changes in mucosa thickness, width of keratinized tissues, marginal bone and bone thickness at the surgical site will be determined at T0-T1. Groups will be further divided into two subgroups based on mucosal thickness of the surgical site at T0 [thin mucosa (≤2.5mm) for Groups-AI/-BI; thick mucosa (>2.5mm) for Groups-AII/-BII]. A linear mixed model for repeated measures will be used for data analyses to determine changes in the dimensions of the peri-implant soft and hard tissues, around two stage-implants placed either conventionally, or in combination with the biocomplex.

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

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: Group-A
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• systemically healthy volunteers

Exclusion Criteria:

  • poorly controlled systemic disease
  • heavy smoking (>20cigs/day)
  • bisphosphonate medication
  • anti-inflammatory drugs
  • bone metabolic diseases or disorders that compromise wound healing
  • immunosuppressive therapy or radiation
  • alcohol intake
  • drug abuse over the past year
  • significant concurrent illness
  • pregnancy/lactation
  • active periodontal disease and compromised oral hygiene (PI ≥25%)

Information from the National Library of Medicine

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


Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Layout table for investigator information
Study Chair: Antonis Konstantinidis, Professor Retired, Dept. of Preventive Dentistry, Periodontology and Implant Biology, School of Dentistry, Aristotle University of Thessaloniki

Publications:
Layout table for additonal information
Responsible Party: Danae A. Apatzidou, Assist. Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03070275     History of Changes
Other Study ID Numbers: ELKE_91480
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Danae A. Apatzidou, Aristotle University Of Thessaloniki:
surgical implant placement
crestal bone
mucosa thickness
stem cells
fibrin glue
collagen fleece

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibrin Tissue Adhesive
Hemostatics
Coagulants