A Phase 3 interventional study of OraVerse in Soft Tissue Injuries, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 5 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Cairo University · Phase 3, Interventional, and Supportive care
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
Local anesthesia is the most common method for pain control during any dental procedures, but it is also one of the factors that can trigger discomfort and anxiety in children. Local anesthetics are primarily used to reversibly block action potentials that create impulse conduction along neural axons carrying sensory or motor signals. This occurs by blocking voltage-gated sodium channels. A prospective study of 320 children by College et al., (2000), reported soft tissue trauma frequency as 18%, 16%, 13% and 7% in children who are; less than 4, 4-7, 8-11 and more than 12 years old, respectively following inferior alveolar nerve block anesthesia and its numbing effect.
The search for a pharmacologic means of minimizing postoperative soft tissue anesthesia has focused on phentolamine mesylate (PM), where an injectable form has been developed. Following the administration of local anesthetic with vasoconstrictor, a subsequent phentolamine injection into the same location enhances the redistribution of the local anesthetic away from the injection site as it is an alpha-adrenergic blocking agent, explaining the more rapid return of normal intraoral and perioral sensation.
An intra-oral preparation of PM for the reversal of soft tissue anesthesia was approved by the FDA in May 2008, to be used for patients > 6 years of age and weighing > 15 kg. Later, in March 2016, the FDA approved its use in pediatric patients 3 years and older. Dosage form of OraVerse (phentolamine mesylate) is 0.4 mg/1.7 ml solution per cartridge. Its maximum dose is 2 cartridges in adults. The first published placebo-controlled phase two study reported that, in 10- to 58-year-old dental patients, an injection of phentolamine, at a one-to-one ratio at the site of the previous injection of local anesthesia, accelerated median recovery time to normal sensation of the upper and lower lips by 85 minutes.
64 studies on the registry are indexed under Soft Tissue Injuries; 7 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 51 interventional studies indexed under Soft Tissue Injuries.
Browse Soft Tissue Injuries studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Children aged 5-7 years.
Exclusion Criteria:
participants receive phentolamine mesylate (Oraverse) injection after the completion of their dental procedures with ratio 1:1 to LA in children weighed 30 kg and more while in children less than 30 kg only half of the amount of the cartridge is administrated.
Drug: OraVerse
participants don't receive any reversal agent or placebo after the completion of their dental procedures.
Phentolamine mesylate is a vaso-dilator that was used for treating dermal necrosis and severe hypertension cases since 1952. It is alpha-adrenergic antagonist. Oraverse is supplied in a dose equal to the amount of LA taken in adults and children with weights more than 30 kg. While in children less than 30 kg, it is advised to use only half carpule according the manufacturer's instructions.
Also known as: phentolamine mesylate
Time to return to normal function
it is the time needed for the soft intraoral tisues e.g lips, tongue to return to their normal functions after local anaesthesia
Time frame: 2 hours
Incidence of self-inflicted soft tissue trauma
we observe clinical signs of redness, swelling, hematoma or ulcers due to lip biting at dismal of each participant
Time frame: 2 hours
Cost effectiveness of oraverse
we measure the cost effectiveness of the intervention drug through Incremental cost-effectiveness ratio (ICER) ICER=(C1-C0)/ (E1-E0) C1= cost of intervention drug C0= cost of control E1= effect of intervention drug E0= effect of control
Time frame: Through the completion of the study, with average 1 year
post-operative pain by 170 mm Heft-parker visual analogue scale (VAS)
it is 170mm scale from 0 to 170 mm and it represents * no pain: corresponds to 0 mm. * mild pain: greater than 0 mm and less than or equal to 54 mm and included the description of faint and weak pain. * moderate pain: greater than 54 mm and less than 114 mm. * severe pain: equal to or greater than 114 mm to 170 mm and includes the description of strong and intense pain
Time frame: the following 24 hours
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Apr 2026, 9 months after the start.
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Studies of the drug tested here: Phentolamine