NCT03070275: Implant_bone

Preservation of Alveolar Crestal Bone From Implant Placement to Implant Exposure Using Autologous Alveolar Bone-Marrow Derived Mesenchymal Stem Cells (aBM-MSCs)

Completed Phase 1/Phase 2 Last updated 31 October 2018

What this trial tests

Phase 1/Phase 2 trial testing Biocomplex: aBM-MSCs/fibrin glue/collagen fleece in Implant Therapy in 20 participants. Completed in 1 December 2017.

Timeline

1 February 2015

Primary endpoint
1 June 2017

1 December 2017

Quick facts

Lead sponsor	Aristotle University Of Thessaloniki
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	1 February 2015
Primary completion	1 June 2017
Estimated completion	1 December 2017

Drugs / interventions tested

• Biocomplex: aBM-MSCs/fibrin glue/collagen fleece — full drug profile →
• Two-stage surgical implant placement

Conditions studied

• Implant Therapy — all drugs for Implant Therapy →

Sponsor

Aristotle University Of Thessaloniki

Who can join

Adults 20 to 60, any sex, with Implant Therapy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal Stromal Cell-Based Bone Regeneration Therapies: From Cell Transplantation and Tissue Engineering to Therapeutic Secretomes and Extracellular Vesicles.
   Marolt Presen D, Traweger A, Gimona M, Redl H. · · 2019 · cited 104× · PMID 31828066 · DOI 10.3389/fbioe.2019.00352
2. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
3. Emerging Landscape of Mesenchymal Stem Cell Senescence Mechanisms and Implications on Therapeutic Strategies.
   Wang J, Zhang M, Wang H. · · 2024 · cited 13× · PMID 39144566 · DOI 10.1021/acsptsci.4c00284
4. Neural crest-derived mesenchymal stem cells: Fates and perspectives.
   He YL, Chen SJ, Xia DS, Song WP. · · 2025 · PMID 41025106 · DOI 10.4252/wjsc.v17.i9.107689