Efficacy of Local Delivery of MicroRNAs and MicroRNA Inhibitors in Promoting Osteogenesis and Modulating Local Inflammation: A Pilot Clinical Trial Using the Tooth Socket Model

NCT02579187 Phase 1 WITHDRAWN

To evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAs, and/or microRNA inhibitors, in the promotion of osteogenesis and modulation of the inflammatory response on the basis of different clinical, radiographic, histologic and biomolecular outcomes in post-extraction socket defects in humans.

Details

Lead sponsor	Gustavo Avila-Ortiz DDS, MS, PhD
Phase	Phase 1
Status	WITHDRAWN
Start date	2025-12-31
Completion	2030-09

Conditions

• Tooth Extraction Status Nos

Interventions

• tooth extraction
• CBCT scan
• Anesthesia
• clinical measurements
• Biodegradable sponge (type I bovine collagen)
• 10µg of pSil-miR200c
• cross mattress suture
• 10µg of PMIS miR200a plasmids
• 5µg of pSil-miR200c and 5µg of PMIS miR200a
• Blood

Primary outcomes

• Percent of mineralized tissue upon histomorphometric analysis of bone core biopsies — at 16 weeks postoperatively
  compared using exact Wilcoxon rank sum tests

Countries

United States