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Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children

RecruitingNAAges 7 Years - 11 YearsAllBritish University In Egypt
NCT07835191 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study aims to determine whether pre-cooling and sweet-tasting solutions, alone or combined with topical anesthesia, provide better pain control during dental local anesthesia in children. It has two phases: Phase 1: Identify the children's preferred sweet-tasting solution among xylitol, monk fruit, erythritol, and honey. Phase 2: A randomized controlled trial comparing 7 groups involving pre-cooling, sweet solution, topical anesthesia, and their combinations. The primary outcome is pain measured by VAS, while secondary outcomes include SEM behavioral response, heart rate, and oxygen saturation. The planned sample is 220 children.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age group 7-11 years 2. Patients requiring infiltration anesthesia to fulfill dental therapeutic needs 3. Frankl behavior scale 3 and 4 Exclusion Criteria: 1. Failure to provide assent or consent 2. Allergy from local anesthetic solution 3. Systemic diseases such as diabetes that could affect pain perception 4. History of abscess or fistula at site of injection
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What it tests

  • Dental anesthesia
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Where

1 site
Faculty of Dentistry, British University in Egypt
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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