Harnessing Chronomodulation to Enhance Osteogenesis
Status:
Suspended
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
Chronotherapy is an emerging field in biomedicine that leverages on fine-tuning the timing of
drug delivery to obtain a therapeutic effect. Dr. Tamimi and his team have successfully
harnessed chronotherapy using NSAIDs to enhance bone healing in a murine fracture model.
Unpublished findings revealed that mice receiving carprofen for 3 days post-fracture
exclusively during activity hours exhibited superior bone healing outcomes in comparison to
specimens that received the same drug during resting hours.
This is a 3-arm RCT aimed at evaluating the effect of different chronotherapeutic NSAID
regimens on intraoral bone healing in humans using an extraction socket healing model in the
context of an early implant placement protocol.
The primary aim is to elucidate whether there are differences in osteogenesis and in the
characteristics of the newly formed bone between patients following different post-operative
NSAID chronotherapeutic protocols. Secondary endpoints of interest include assessment of
alveolar bone and soft tissue dimensional changes between pre- and post-extraction, implant
insertion torque, serum CRP levels, wound healing index and patient-reported discomfort at
different time points.
If proven beneficial, the proposed chronotherapeutic approach could be readily implemented in
clinical practice as a standalone therapy or as a valuable complement to existing
standard-of-care protocols, due to its simplicity, safety and cost-effectiveness.
Phase:
Phase 4
Details
Lead Sponsor:
Gustavo Avila-Ortiz DDS, MS, PhD University of Iowa