NCT05448807 is a Phase 3 clinical trial of OraVerse in Soft Tissue Injuries, sponsored by Cairo University.

Who is sponsoring NCT05448807?

NCT05448807 is sponsored by Cairo University.

What drugs are being tested in NCT05448807?

Interventions in NCT05448807: OraVerse.

What condition does NCT05448807 study?

NCT05448807 studies Soft Tissue Injuries.

Is NCT05448807 still recruiting?

NCT05448807 is currently recruiting now. Last updated 6 July 2025.

Last reviewed 2025-07-06 · How we verify

NCT05448807

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 6 July 2025

What this trial tests

Phase 3 trial testing OraVerse in Soft Tissue Injuries in 100 participants. Currently enrolling.

Timeline

5 July 2025

Primary endpoint
20 April 2026

1 June 2026

Quick facts

Lead sponsor	Cairo University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	100
Start date	5 July 2025
Primary completion	20 April 2026
Estimated completion	1 June 2026
Sites	1 location across Egypt

Drugs / interventions tested

OraVerse — full drug profile →

Conditions studied

Soft Tissue Injuries — all drugs for Soft Tissue Injuries →

Sponsor

Cairo University

Who can join

Adults 5 to 7, any sex, with Soft Tissue Injuries. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Time to return to normal function
Time frame: 2 hours
it is the time needed for the soft intraoral tisues e.g lips, tongue to return to their normal functions after local anaesthesia

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of OraVerse

Trials testing the same drug.

NCT02995291 — Reversing the Effects of 0.5% Bupivacaine · Phase 4 · completed

Other recruiting trials for Soft Tissue Injuries

Currently open trials in the same condition.

NCT07293702 — IASTM Effects on Pain, Functionality, and Proprioception in Subacromial Impingement · NA · recruiting
NCT05679284 — A Cross-Sectional Observational Study on Retained Drug Needle Fragments in People Who Use Intravenous Drugs · recruiting

Other Cairo University trials

Trials by the same sponsor.

NCT04155528 — Effect of Music Therapy on Postoperative Health Outcomes · NA · not yet recruiting
NCT07363239 — CBCT-Based Safety Distance for Implant Placement Near the Inferior Alveolar Canal · not yet recruiting
NCT07374575 — Egyptian Dental Professionals' Perspectives on the Oral Microbiome and Exosomes · not yet recruiting
NCT07381153 — In-Vitro Cytotoxicity Assessment of INOX (Nanoksa G Plus) Polymer Discs · not yet recruiting
NCT07375394 — 3D-Printed Extraoral Camera for Standardized Dental Photography · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05448807 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cairo University
Last refreshed: 6 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05448807.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing