NCT05448807 Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children
| NCT ID | NCT05448807 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cairo University |
| Condition | Soft Tissue Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-05 |
| Primary Completion | 2026-04-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2025-07-05 with a primary completion date of 2026-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Local anaesthesia is considered one of the most alarming and non-comfortable dental procedures for children. This goes back to the persisting effect of the local anaesthesia after finishing dental procedures. The effect of Local anaesthesia can last from 3 to 5 hours due to the presence of vasoconstrictor. The U.S Food and Drug Administration (FDA approved the use of phentolamine mesylate (Oraverse) in May 2008 to be used as a drug in reversing the numbing effect of Local anaesthesia by decreasing the time needed to restore the normal functions of the mouth
Eligibility Criteria
Inclusion Criteria: Children aged 5-7 years. * Patients in need of dental procedures requiring local anaesthesia. * Healthy Children without any systemic or mental disorders. * Normal lip sensation before administration of LA. * Normal paediatric functional assessment battery (pFAB) for smiling, speaking and drinking and absence of drooling. Exclusion Criteria: * Children seeking dental treatment that does not necessitate local anaesthesia. * Children who didn't achieve profound numbness requiring additional anaesthesia. * Children who lack the ability to distinct the anaesthetised numb side from the non-anaesthetised one. * Children who are not willing to participate in the study.
Contact & Investigator
mahmoud hamdy, professor
STUDY CHAIR
main supervisor
Frequently Asked Questions
Who can join the NCT05448807 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 7 Years, studying Soft Tissue Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05448807 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT05448807 currently recruiting?
Yes, NCT05448807 is actively recruiting participants. Contact the research team at alaa.saad@dentistry.cu.edu.eg for enrollment information.
Where is the NCT05448807 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT05448807 clinical trial?
NCT05448807 is sponsored by Cairo University. The principal investigator is mahmoud hamdy, professor at main supervisor. The trial plans to enroll 100 participants.