Phentolamine (OraVerse) to reverse dental numbness in children
A Randomized Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Decreasing Self- Inflicted Soft Tissue Trauma Following Local Anaesthesia Injection for Dental Procedure in Children: Randomized Clinical Trial
This tests whether OraVerse (phentolamine mesylate) can shorten the numbness children aged 5–7 experience after dental local anesthesia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 5 Years to 7 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, El Manial) |
| Trial ID | NCT05448807 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional study at Cairo University enrolls healthy children aged 5–7 who require dental procedures with local anesthesia; after standard local anesthetic with a vasoconstrictor, participants receive phentolamine mesylate (OraVerse) to reverse soft-tissue numbness. Phentolamine is an alpha-adrenergic blocker that promotes redistribution of the anesthetic away from the injection site, which can speed the return of intraoral and perioral sensation. The protocol measures time to return of normal lip sensation and simple functional tasks (smiling, speaking, drinking) and records soft-tissue injury and adverse events. Outcomes will determine how quickly and safely oral sensation and function return after OraVerse administration.
Who should consider this trial
Good fit: Healthy children aged 5–7 who need dental procedures with local anesthesia, have normal lip sensation and oral function before anesthesia, and can follow simple instructions are ideal candidates.
Not a fit: Children who do not receive local anesthetic with a vasoconstrictor, who do not achieve profound numbness, who cannot distinguish the numb side from the normal side, or who are unwilling to participate are unlikely to benefit.
Why it matters
Potential benefit: If successful, children could regain normal mouth sensation and function sooner, reducing accidental lip or cheek biting and post-procedure discomfort.
How similar studies have performed: Phentolamine mesylate (OraVerse) is already FDA-approved for reversing soft-tissue dental anesthesia in pediatric patients and prior studies have shown it can shorten numbness.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo, El Manial
- Cairo University — Cairo, El Manial, Egypt (Recruiting)
Study contacts
- Study coordinator: alaa saad abourawash
- Email: alaa.saad@dentistry.cu.edu.eg
- Phone: 01144942076
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.