Clinical studies
Every product in the Nivellipso catalog is backed by peer-reviewed evidence or in-house clinical data. Full study documents are available on request to licensed dental practices.
Selected publications
Helix Aligner Treatment Efficacy — Prospective Multicenter Study, 2024
- Sample size
- n = 312 patients across 14 practices
- Duration
- 18-month follow-up
- Outcomes
- Occlusal outcome scores (PAR index), patient-reported satisfaction, chair-time per appointment
- Finding
- Mean PAR score reduction of 79.4% (±6.2%). Mean chair-time 23% lower versus historic fixed-appliance benchmarks in the same practices.
- Status
- Published — available upon request
Sapphire Bracket Friction Coefficient versus Ceramic Alternatives, 2023
- Method
- In vitro pin-on-disk tribometry; Instron tensile testing with standardised 0.019×0.025" NiTi wire
- Controls
- Four leading polycrystalline ceramic bracket systems (blinded)
- Finding
- Nivellipso single-crystal sapphire brackets exhibited a kinetic friction coefficient of 0.068 µ vs. polycrystalline ceramic mean of 0.142 µ — a 52% reduction.
- Status
- In-house data — full technical report available upon request
NiTi Archwire Force-Deflection Comparison Across Manufacturers, 2022
- Method
- Three-point bending test per ISO 15841 at 37°C (simulated oral temperature)
- Sample
- Nivellipso NV-NI-014 vs. five competitor 0.014" round NiTi wires, 10 specimens each
- Finding
- NV-NI-014 delivered consistent light force across the clinically relevant deflection range (0–3 mm). Batch-to-batch coefficient of variation: 3.1% vs. competitor mean 8.7%.
- Status
- In-house data — full technical report available upon request
Request study documents
Full study reports, ISO 15841 test certificates, clinical investigation files, and post-market clinical follow-up (PMCF) summaries are available to licensed dental and orthodontic professionals. Verification of your professional licence is required.
Request documents — clinical@nivellipso.comPost-market surveillance
Nivellipso operates an ongoing post-market clinical follow-up (PMCF) programme for all Class IIa devices. Adverse event data is collected from registered practices, analysed quarterly, and reported to our EU notified body (BSI, CE 0123) and to Swissmedic. No serious adverse events attributable to Nivellipso devices have been reported since commercial launch.