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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)

â—‹

â—‹

â—‹

  

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

â—‹

â—‹

  

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)

â—‹

â—‹

â—‹

 

X

Detailed independent clinical assessment ICDAS, BoP (Scotland only)

â—‹

 

â—‹

  

EQ-5D-5 L

â—‹

  

â—Ź

 

OHIP-14

â—‹

  

â—Ź

 

Pain - seeking professional care because of pain

â—‹

â—‹

   

Oral health behaviour

â—‹

  

â—Ź

 

Redemption of toothpaste prescriptions

â—‹

â—‹

â—‹

 

X

Adverse reactions

 

â—‹

   
  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. â—Ź Postal Questionnaire
  4. X NHS centralised dental databases