Autogenous Mesenchymal Stem Cell Culture-Derived Signalling Molecules as Enhancers of Bone Formation in Bone Grafting

Launched by PONTIFICIA UNIVERSIDADE CATÓLICA DO RIO GRANDE DO SUL · Aug 1, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to improve bone healing and regeneration in patients who have significant bone loss in their upper jaw, specifically in those needing dental implants. The researchers want to see if using a special mixture of cells from the patient's own fat (called mesenchymal stem cells) along with a synthetic bone substitute can enhance the quality and amount of bone formed during the grafting process. The study will involve 20 participants who are over 35 years old, have very little remaining bone in their upper jaw (less than 5 mm), and require bone augmentation to support dental implants.

If you participate in this trial, you will undergo a minor outpatient procedure to collect fat from your abdomen. This fat will be processed to obtain the necessary cells for the study. You will have bone grafts placed in both sides of your upper jaw, with one side receiving the special mixture and the other side receiving a standard treatment for comparison. After six months, you will be assessed for implant placement and the effectiveness of the graft. It's important to note that certain health conditions, like smoking or specific diseases that affect healing, may exclude you from participating. Overall, this trial aims to find better ways to support bone healing, which could lead to improved outcomes for patients needing dental implants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • patients \>35 years-old.
• • presenting highly atrophic fully edentulous maxilla (residual bone height \<5 mm).
• • In need of bilateral sinus floor augmentation aiming full mouth implant-supported rehabilitation.
• • having teeth extraction at least 8 weeks prior to bone augmentation.
• Exclusion Criteria:
• • smokers, illicit drug users and alcohol daily consumers.
• • patients with metabolic and/or systemic diseases leading to impaired healing (e.g. decompensated diabetes, leukocyte or coagulation disorders, immunosuppression).
• • history of radiotherapy in the head or neck region.
• • bisphosphonate-based therapy recipients.
• • intolerant to general/local anesthesia.