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. 2017 Dec 28;2017(12):CD008072. doi: 10.1002/14651858.CD008072.pub2

NCT02568917.

Trial name or title Effectiveness of ART and conventional treatment ‐ practice‐based clinical trial
Methods Design: parallel RCT, single blind
Country: Brazil
Participants Inclusion criteria
  • Children aged 6‐14 years

  • In good health

  • Spontaneous demand for treatment by parents or legal guardians

  • Whose parents or legal guardians accept and sign the consent form

  • With ≥ 1 occlusal or occlusal proximal caries lesion in primary or permanent molars

  • Only occlusal and/or occlusal‐proximal surfaces with caries lesions with dentin involvement


Exclusion criteria
  • Severe behavioural issues

  • Presence of fistula or abscess near the selected tooth

  • Presence of pulp exposure in the selected tooth

  • Presence of mobility in the selected tooth

Interventions Two treatment arms:
  • Group 1: ART using H‐GIC (Ketac Molar Easy Mix). No local anaesthesia will be used. Infected carious tissue will be removed with hand instruments.

  • Group 2: CT using composite Resin (Bulk Fill). Local anaesthesia can be used if necessary. Access to caries lesion will be done using a round bur. Infected carious tissue will be removed with hand instruments.

Outcomes Primary outcome
  • Restoration survival


Secondary outcome
  • Longevity of the tooth

  • Cost‐efficacy assessment

  • Preference of the treatments by dentists

Starting date January 2016
Contact information Professor Daniela P Raggio
danielar@usp.br
Notes