PMCF survey for a temporary crown & bridge material

The brief

• Generate clinician-reported evidence on real-world performance and safety for post-market surveillance.
• Quantify post-operative sensitivity, fractures, and retention failure in provisional restorations.
• Capture dentist and patient satisfaction with esthetics, function, and handling in routine practice.
• 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, retention performance, and esthetic outcomes for post-market surveillance

Our approach

A structured PMCF survey of 75 general practice dentists across the US, Spain, and Romania, run under MRS code of conduct

• Designed a screened questionnaire covering product usage, experience, safety, performance, and esthetics.
• Fielded online to 75 licensed general practice dentists across the US, Spain, and Romania.
• Screened on licensing, job role, provisional restoration volumes, and current use of the product.
• Built in an adverse-event and complaint reporting route, with confidentiality safeguards throughout.

Key outcomes

A clean, analysis-ready dataset evidencing high satisfaction and near-zero complication rates, with adverse-event flagging

• Captured 75 QC'd responses across three markets, weighted towards high-volume provisional restoration practices.
• Quantified agreement on overall performance, patient satisfaction, esthetics, and absence of adverse reactions.
• Measured complication rates across post-operative sensitivity, fracture, and retention failure, all minimal.
• Delivered a cleaned, coded raw data file ready for PMCF reporting and trend analysis.