PMCF survey for a universal composite

The brief

• Generate clinician-reported evidence on real-world performance and safety for post-market surveillance.
• Quantify post-operative sensitivity, fractures, marginal and surface staining, and luster issues.
• Capture satisfaction with radiopacity, colour matching, shade range, and esthetic outcomes.
• Identify any residual risks or unforeseen issues and deliver a dataset ready to feed the PMCF report.

The problem

No current clinician-reported evidence on real-world safety, restoration durability, and shade-matching performance for post-market surveillance

Our approach

A structured PMCF survey of 150 general practice dentists across the US and Russia, run under MRS code of conduct

• Designed a screened questionnaire covering usage history, safety, restoration performance, and esthetics.
• Fielded online to 150 licensed general practice dentists across the US and Russia.
• Screened on licensing, job role, competitor brand usage, and anterior and posterior case volumes.
• Built in an adverse-event and complaint reporting route, with confidentiality safeguards throughout.

Key outcomes

A clean, analysis-ready dataset covering safety, restoration performance, esthetics, and shade range, with adverse-event flagging

• Captured 150 QC'd responses across two markets, spanning anterior, posterior, repair, and core build-up use.
• Quantified agreement on radiopacity, adverse reactions, sensitivity, fractures, staining, luster, and colour matching.
• Measured complication rates and captured clinician feedback on the shade range available.
• Delivered a cleaned, coded raw data file ready for PMCF reporting and trend analysis.