Last reviewed · How we verify
Self-adhesive resin
Self-adhesive resin is a Small molecule drug developed by Aga Khan University. It is currently in Phase 3 development for Dental restorations and bonding applications. Also known as: Seal and Protect, Dentsply.
A self-adhesive resin formulation that bonds to dental or oral surfaces to provide mechanical retention and therapeutic delivery.
Self-adhesive resin is used in dental applications, including direct composite restorations, to treat conditions such as tooth diseases, dental leakage, and gingival and periodontal disease. The resin is available under various trade names, including Futurabond, and is used in clinical trials to compare its performance with other adhesives.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Self-adhesive resin |
|---|---|
| Also known as | Seal and Protect, Dentsply |
| Sponsor | Aga Khan University |
| Modality | Small molecule |
| Therapeutic area | Dentistry |
| Phase | Phase 3 |
Mechanism of action
Self-adhesive resins are dental materials that chemically bond to tooth structure and restorative surfaces without requiring separate adhesive application. They typically contain functional monomers that interact with hydroxyapatite and collagen in tooth structure, creating a micromechanical and chemical bond while simultaneously setting through polymerization.
Approved indications
- Dental restorations and bonding applications
Common side effects
Key clinical trials
- Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth (EARLY_PHASE1)
- Two-Year Clinical Performance of Self-Cured Resin Composite in Comparison to Light-Cured Bioactive Resin Composite in Restoring Occlusal Cavities of Posterior Teeth. (NA)
- Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars (NA)
- Clinical Study of a 3D Shaded Zirconia for Chairside CAD/CAM Restorations
- HEMA-free Universal Adhesives for Restoring Non-carious Cervical Lesions (NA)
- DETERMINATION OF THE EFFECTS OF STAINLESS STEEL CROWNS CEMENTED WITH RESIN CEMENTS ON INTERLEUKIN-10, 12, 18 LEVELS IN GINGIVAL CREVICULAR FLUID (NA)
- Injection Molding Technique: A Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children (PHASE4)
- A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Self-adhesive resin CI brief — competitive landscape report
- Self-adhesive resin updates RSS · CI watch RSS
- Aga Khan University portfolio CI
Frequently asked questions about Self-adhesive resin
What is Self-adhesive resin?
How does Self-adhesive resin work?
What is Self-adhesive resin used for?
Who makes Self-adhesive resin?
Is Self-adhesive resin also known as anything else?
What development phase is Self-adhesive resin in?
Related
- Manufacturer: Aga Khan University — full pipeline
- Therapeutic area: All drugs in Dentistry
- Indication: Drugs for Dental restorations and bonding applications
- Also known as: Seal and Protect, Dentsply
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing