Comparing vibration and cold stimuli for pain relief in children
Official title: Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception During Needle Insertion in Children
Run by Alexandria University · NCT06841601 · Data updated 2026-11-12
This study is testing whether using vibration or cold from the Buzzy® device can help reduce pain for kids aged 5-9 during dental work compared to regular numbing gel.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 9 Years |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Status | Recruiting |
| Started | February 23, 2025 |
| Main results expected | March 25, 2025 |
| Study ends | March 25, 2025 |
| Registry record updated | February 24, 2025 |
| Trial ID | NCT06841601 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy children aged 5-9 years who are undergoing simple restorative dental procedures and exhibit positive behavior during preoperative assessments.
✕Probably not a fit
Patients with allergies to local anesthesia, acute infections, or special health care needs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the Buzzy® device in reducing pain perception during local anesthesia in children aged 5-9 years. Participants will be randomly assigned to receive either vibration, cold stimuli, or conventional topical anesthetic gel before undergoing simple restorative dental procedures. Pain response will be measured using the Visual Analog Scale (VAS) and the Subjective Experience of Pain (SEM) scale. The goal is to determine which method provides the best pain control for pediatric patients.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques for children undergoing dental procedures.
How similar studies have gone: While there have been studies on pain management in pediatric dentistry, the specific comparison of vibratory versus cold stimuli is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients indicated for simple restorative procedures. 2. Children with physical status ASA I, II. 3. Children with no learning disabilities 4. Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale. 5. Patients whom parents will give consent to participate Exclusion Criteria: 1. Patients allergic to local anesthesia or having a family history of allergy to local anesthesia. 2. Patients with acute oral or facial infection (swelling and/or cellulites) 3. Having active sites of pathosis in the area of injection that could affect anesthetic assessment. 4. Children with special health care needs.
Where it's running
-
Faculty of Dentistry- Alexandria University
Alexandria, Egypt Recruiting
Study contacts
- Study coordinator: Dina A Sharaf, PhD
- Email: dina.sharaf@alexu.edu.eg
- Phone: 01005319290
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.