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NCT03911336
Harnessing Chronomodulation to Enhance Osteogenesis
Phase 4 trial testing Group A - test:Tooth extraction and intake of NSAID and a non-NSAID in Tooth Loss. Withdrawn.
1 January 2023
Quick facts
| Lead sponsor | University of Iowa |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 1 January 2023 |
| Primary completion | 1 January 2023 |
| Estimated completion | 1 January 2023 |
Drugs / interventions tested
- Group A - test:Tooth extraction and intake of NSAID and a non-NSAID — full drug profile →
- Group B - Control 1: tooth extraction and intake of NSAID and a non-NSAID — full drug profile →
- Group C - Control 2: tooth extraction and intake of a Non-Nsaid — full drug profile →
Conditions studied
- Tooth Loss — all drugs for Tooth Loss →
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 Unpublished findings revealed that mice receiving carprofen for 3 days post-fracture exclusively during activity hours exhibited superior bone healing outcomes in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.
Verify or expand the search:
- PubMed search for NCT03911336
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Related trials
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03911336 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Iowa
- Last refreshed: 21 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03911336.
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