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NCT03911336

Harnessing Chronomodulation to Enhance Osteogenesis

Withdrawn Phase 4 Last updated 21 June 2022
What this trial tests

Phase 4 trial testing Group A - test:Tooth extraction and intake of NSAID and a non-NSAID in Tooth Loss. Withdrawn.

Timeline
1 January 2023
Primary endpoint
1 January 2023
1 January 2023

Quick facts

Lead sponsorUniversity of Iowa
PhasePhase 4
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Start date1 January 2023
Primary completion1 January 2023
Estimated completion1 January 2023

Drugs / interventions tested

Conditions studied

Sponsor

University of Iowa

Who can join

Adults 18 to 85, any sex, with Tooth Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 Unpublished findings revealed that mice receiving carprofen for 3 days post-fracture exclusively during activity hours exhibited superior bone healing outcomes in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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Tooth Loss

Currently open trials in the same condition.

Other University of Iowa trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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