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Table 1 Summary of methods used to collect outcome measures

From: Protocol for a Randomised controlled trial to Evaluate the effectiveness and cost benefit of prescribing high dose FLuoride toothpaste in preventing and treating dEntal Caries in high-risk older adulTs (reflect trial)

  Baseline Elective and non-elective visits to the dentist over 3 year follow upa 36 months Annual Questionnaire National Database
Clinical Status (full dental chart)   
Treatment details Check ups, restorations, endodontics, extractions (reason for treatment in CRF and all NHS treatments in national datasets) Prescription of toothpaste (date and amount prescribed) Relevant medical history and medication    X
Healthcare costs GDP completed CRF: payment mechanism (NHS/private) and charges levied Dental treatment received in other settings (patient element of CRF) NHS costs from national data sets Non NHS treatment costs in patient element of CRF)   X
Detailed independent clinical assessment ICDAS, BoP (Scotland only)     
EQ-5D-5 L     
OHIP-14     
Pain - seeking professional care because of pain    
Oral health behaviour     
Redemption of toothpaste prescriptions   X
Adverse reactions      
  1. adentists should invite participants to attend practice at least once a year
  2. Dental Practice – CRF (includes both GDP and participant completed elements)
  3. Postal Questionnaire
  4. X NHS centralised dental databases