Status:
NOT_YET_RECRUITING
Effect of Starpen Injection Device Versus Conventional Syringe During Anesthesia and Extraction of Primary Molars
Lead Sponsor:
Cairo University
Conditions:
Pain Perception of the New Device
Eligibility:
All Genders
6-8 years
Phase:
NA
Brief Summary
To evaluate the effect of Starpen device on pain perception during anesthesia and extraction of maxillary primary molars.
Detailed Description
After enrollment of the patients according to the eligibility criteria, taking full medical , dental history and informed consents from the parents. Clinical and radiographic examination will be done ...
Eligibility Criteria
Inclusion
- Children aged 6-8 years
- Cooperative children ( rating 3 or 4 based on the Frankl behavior scale )
- Medically fit children (ASA I )
- Children mentally capable of communication
- First dental visit
- Patient requiring extraction of upper primary molars due to root caries , crown fractures, periapical disease and failed pulpotomies
- No acute dental pain
Exclusion
- Children with a behavioral management problem
- Parental refusal of participation
- Children with previous history of local anesthesia injection
- Medically unfit children (other than ASA I )
- Uncooperative children ( other than Frankl 3,4)
- Children under medications ( antibiotics and analgesics ) for the previous 48 hours that could alter the pain perception
- Teeth that showed any signs of mobility , ankylosis or root resorption affecting more than one third the root
- Acute dental pain
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT07156032
Start Date
January 1 2026
End Date
October 1 2026
Last Update
September 4 2025
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