RecruitingPhase 3

Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children

Egypt100 participantsStarted 2025-07-05

Plain-language 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

Who can participate

Age range5 Years – 7 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Time to return to normal function

Timeframe: 2 hours

Trial details

NCT IDNCT05448807

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-20

Contact for this trial

alaa saad abourawash

01144942076 alaa.saad@dentistry.cu.edu.eg

View on ClinicalTrials.gov More Soft Tissue Injuries trials