Tracker
Program tracker
Every program claiming to regenerate dental tissue, graded on the evidence behind it. Tiers run from T1 (lab work) to T5 (replicated human results); how tiers are assigned.
- T1 · In vitro / mechanism
- T2 · Animal result
- T3 · Small or narrow human data
- T4 · Human efficacy or safety, single programme
- T5 · Replicated human efficacy
| Program | Route | Status | Tier |
|---|---|---|---|
| Anti-USAG-1 antibody (TRG-035) Toregem BioPharma / Kyoto University | whole-tooth | Phase I single-ascending-dose safety study in adults completed according to sponsor materials (Kitano Hospital / Kyoto University Hospital, 2024-2025); Japanese orphan drug designation for severe congenital partial anodontia (Sep 2025); PMDA clinical trial notification investigation for Phase IIa completed 17 August 2026; Phase II financing disclosed 19 May 2026. A 2026 Journal of Oral Biosciences paper from the antibody's originators proposes MRI/CT imaging biomarkers as surrogate endpoints for pediatric tooth-regeneration trials, but the paper includes no human data. A February 2026 review by Moradi et al. maps USAG-1 expression to gingival fibroblast and epithelial subsets and restates the clinical timeline. No peer-reviewed human safety results and no public evidence of tooth induction in a person. | T4 |
| Pulp and dentine repair (DPSC/SHED grafts, small molecules) Multiple academic groups (Xuan et al. autologous pulp stem cell trial; Sharpe lab GSK-3 antagonist work) | repair | This is where human data actually is: a randomized, controlled trial of autologous pulp stem cell grafts in immature permanent incisors (26 patients evaluated, 24-month imaging) reported continued root development and regenerated pulp. Tideglusib dentine repair is preclinical; cell-free scaffolds and biomimetic enamel remineralization address surface lesions, not enamel regrowth. Clinically relevant regeneration, but categorically different from growing a whole tooth. A 2026 small randomized trial of platelet-rich fibrin versus mineral trioxide aggregate for direct pulp capping in 20 adult molars reports a borderline larger dentin-bridge volume with PRF at six months, with clinical outcomes indistinguishable from MTA. | T3 |
| Bioengineered tooth germ (organ germ transplant) Tsuji lab lineage (Ikeda et al., RIKEN / Tokyo University of Science) | whole-tooth | Fully functional whole-tooth replacement demonstrated in adult mice (2009). Human cell sourcing and developmental control remain major gaps; no human protocol has been proposed. A 2025 study by Kim et al. shows that lingual-buccal positional memory persists in dissociated and reaggregated mouse dental mesenchyme, adding a spatial-patterning requirement to reconstitution protocols. A 2024 chemically defined culture study by Zhang et al. supports mouse tooth reconstitution and BMP-driven enamel induction, and a 2025 study by Zhang and Yelick reports tooth-like mineralized tissues, including periodontal-ligament-like tissue with Sharpey's fibers, from recellularized decellularized porcine tooth bud scaffolds in adult minipigs. A 2025 study by Birjandi and Sharpe finds that the inductive tooth germ secretome and small extracellular vesicles shift epithelial signaling but are not sufficient to replace living mesenchyme for tooth induction in mice. | T2 |
| Dental epithelial organoids Academic laboratories (e.g. Hemeryck et al., KU Leuven / UHasselt) | component | Human dental epithelial organoids recreate enamel-forming developmental tissue. A powerful model of cell behavior; the work sits at the organoid/model boundary, not at a replacement tooth. A 2026 study by Patni et al. reports that a soluble Notch agonist matures human ameloblast organoids and produces enamel-like mineral under the mouse kidney capsule; a 2026 protocol by Nakashima et al. induces PITX2-positive embryonic oral epithelium from human iPSCs. A 2025 study by Hasan et al. reports that a biomimetic elastin-like recombinamer matrix nucleates enamel-like mineral on acid-etched human enamel and dentine ex vivo, restoring stiffness, hardness, and wear resistance. | T2 |
| Tooth root organoids / whole-tooth reassociation Academic laboratories (e.g. Syed-Picard lab, University of Pittsburgh) | component | Root-like organization from human dental stem cells is encouraging. Eruption, crown formation, innervation, and periodontal integration are unresolved. A 2026 scaling study by Calabrese et al. finds that smaller root-organoid constructs lose the layered mineral pattern, pointing to a minimum cell mass for proper patterning. | T2 |
Machine-readable export: /data/programs.json (CC BY 4.0).