One-Year Clinical Performance and Insertion Torque Pattern of a Contemporary Tapered Implant System: A Multicentre...

Area of Science:

• Dental Implantology
• Biomaterials Science
• Surgical Innovation

Background:

• Primary implant stability is crucial for osseointegration and determining loading protocols.
• Insertion torque (ITV) and resonance frequency analysis (ISQ) are key metrics for assessing primary stability.
• Contemporary tapered implant designs aim to enhance stability across various bone types.

Purpose of the Study:

• To evaluate the 1-year survival, stability, marginal bone level changes, and safety of the PrimeTaper EV implant system.
• To specifically analyze the insertion torque characteristics of this contemporary tapered implant.
• To provide clinically relevant reference values for implant stability measurements.

Main Methods:

• A multicenter, open-label, single-arm study involving 138 subjects.
• Recorded insertion torque (final and maximum) for machine-driven and manual placements.
• Measured implant stability quotient (ISQ) at placement and restoration.
• Assessed marginal bone level (MBL) radiographically at multiple time points.

Main Results:

• Achieved 1-year implant survival rates of 98.5% (PP) and 98.6% (ITT), exceeding the performance goal.
• Mean final insertion torque was 31.2 Ncm and peak torque was 33.6 Ncm for machine insertions.
• ISQ increased significantly from placement (71.8) to restoration (79.3).
• Marginal bone level change was minimal (-0.16 mm cumulative from placement to 1 year).

Conclusions:

• The PrimeTaper EV implant demonstrates high survival and favorable bone remodeling at 1 year.
• Achieved primary stability values are within recommended guidelines for early loading.
• Torque-curve analysis indicates consistent torque build-up, supporting predictable seating.
• The study provides essential reference values for clinicians managing implant stability.