No needle, no tears? new device aims to make dental shots painless for children
NCT ID NCT07426523
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a needle-free device called INJEX to give local anesthesia to children aged 6-9 during dental procedures. The goal was to see if it causes less pain and anxiety compared to a traditional needle. Researchers measured pain using child and observer scales, and anxiety by checking pulse rate. The results could help make dental visits easier for kids.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- INJEX 30 needle-free injection device
- What this could lead to
- If effective, this device could offer a less painful and less scary way to give local anesthesia to children during dental procedures.
- What could go wrong
- This is a small, completed trial with only 52 children. The device may not work for all kids or all types of dental work, and it still requires a topical gel and local anesthetic.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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52 people
The number who actually took part.
- Started
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May 2025
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 9 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Children aged 6-9 years with no previous dental experience. 2. Children classified as positive or definitely positive according to the Frankl behavior rating scale. 3. Children requiring local anesthesia in the lower primary molar region for therapeutic dental procedures Exclusion Criteria: 1. Children with systemic diseases that contraindicate the administration of local anesthesia or the required dental treatment. 2. Children who have received sedative or analgesic medications within the 3 hours preceding the dental visit \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Pediatric Dentistry, Faculty of Dentistry
Damascus, Rif-dimashq Governorate, Syria