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. 2020 Feb 27;2020(2):CD011024. doi: 10.1002/14651858.CD011024.pub2

NCT03917121.

Trial name or title Pain control of needle‐free versus needle injected LA for pulpotomy of upper primary molars in children
Methods Study design: randomised trial, parallel design
Country: Egypt
Participants Inclusion criteria: apparently healthy (classified as American Society of Anesthesiologists (ASA) I); vital deeply carious maxillary first primary molars indicated for pulpotomy; no previous dental experience; co‐operative behaviour (rating 3 or 4 on Frankl category rating scale)
Exclusion criteria: refuse to give assent to participate or have parents/caregivers refusing to sign the informed consent form
Estimated number of participants to be enrolled: 46
Elligible age range: 6 to 8 years
Interventions Group 1: jet anaesthesia
Group 2 (control): conventional infiltration anaesthesia
Outcomes
  • Pain during pulpotomy: score on Faces Pain Scale‐Revised and score on Sound, Eyes, and Motor (SEM) scale

  • Pain during injection: score on Faces Pain Scale‐Revised and score on Sound, Eyes, and Motor (SEM) scale

  • Need for additional anaesthesia: recorded as a binary (yes/no) outcome

Starting date August 2019
Contact information Lobna S Mohamed (lobna_mohamed@dentistry.cu.edu.eg)
Mariam M Aly (mariam.mohsen@dentistry.cu.edu.eg)
Notes