PMCF survey for a bulk-fill composite

The brief

• Generate clinician-reported evidence on real-world safety and restoration performance.
• Quantify post-operative sensitivity, fractures, marginal and surface staining, and luster issues.
• Capture satisfaction with radiopacity, colour matching, shade range, and esthetic outcomes.
• Deliver a clean, structured dataset ready to feed the PMCF report.

The problem

No current clinician-reported evidence on real-world safety, restoration performance, and esthetic outcomes

Our approach

A structured PMCF survey of 150 general practice dentists across the US and China, screened on product usage and independence

• Designed a screened questionnaire covering usage history, safety, performance, and esthetics.
• Fielded online to 150 general practice dentists across the US and China.
• Screened on licensing, competitor brand usage, and independence from the manufacturer.
• Collected case volumes and complication rates as percentages, with severity follow-ups on each issue.

Key outcomes

A clean, analysis-ready dataset quantifying complication rates and satisfaction across safety and esthetics

• Captured 150 QC'd responses across two markets covering anterior and posterior restorations.
• Quantified agreement on radiopacity, adverse reactions, sensitivity, fractures, staining, and luster.
• Measured complication rates and the share needing intervention, replacement, or endodontic treatment.
• Delivered a cleaned, coded data file ready for PMCF reporting and trend analysis.