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

NCT03070275 | Completed Phase 1

• 1 other identifier: ELKE_91480
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Implant Therapy

Keywords

surgical implant placement; crestal bone; mucosa thickness; stem cells; fibrin glue; collagen fleece

Outcome Measures

Primary Outcomes (1)

• A reduction in the marginal bone levels

  Intra-surgical clinical data: Changes in the vertical distance from the implant shoulder to the alveolar crest in mm

  baseline (implant placement) to 4 months (implant exposure)

Secondary Outcomes (4)

• Radiographic changes in the marginal bone levels

  baseline (implant placement) to 4 months (implant exposure)

• Reduction in the thickness of the buccal/lingual bone

  baseline (implant placement) to 4 months (implant exposure)

• Changes in the alveolar mucosa

  baseline (implant placement) to 4 months (implant exposure)

• Changes in the width of keratised mucosa

  baseline (implant placement) to 4 months (implant exposure)

Study Arms (2)

Group-A

EXPERIMENTAL

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

Control Group-B

ACTIVE COMPARATOR

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

Interventions

Biocomplex: aBM-MSCs/fibrin glue/collagen fleece BIOLOGICAL

Xeno-free, clinical-grade, autologous alveolar bone marrow mesenchymal stem cells enriched with autologous fibrin glue and loaded into a commercially available collagen fleece.

Group-A

Two-stage surgical implant placement PROCEDURE

Implants are surgically placed on the alveolar crest following a two-stage protocol and the manufacture's guidelines with no adjunctives.

Control Group-B

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• systemically healthy volunteers

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Related Publications (1)

• Bakopoulou A, Leyhausen G, Volk J, Koidis P, Geurtsen W. Comparative characterization of STRO-1(neg)/CD146(pos) and STRO-1(pos)/CD146(pos) apical papilla stem cells enriched with flow cytometry. Arch Oral Biol. 2013 Oct;58(10):1556-68. doi: 10.1016/j.archoralbio.2013.06.018. Epub 2013 Jul 18.

  PMID: 23871383 BACKGROUND

Study Officials

• Antonis Konstantinidis, Professor

  Retired, Dept. of Preventive Dentistry, Periodontology and Implant Biology, School of Dentistry, Aristotle University of Thessaloniki

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor is not aware of the treatment modality
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Professor

Model Details: Prospective, randomised, single blind, control clinical trial

Study Record Dates

• First Submitted: February 25, 2017
• First Posted: March 3, 2017
• Study Start: February 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 1, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share