Soft Tissue InjuriesPhase 3NCT05448807
Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children
A Phase 3 study testing OraVerse in people with Soft Tissue Injuries, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Injuries
- What is being tested?
- OraVerse
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2025to Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, El Manial, 11562
Alaa Saad, bachelor degree of science, 00201144942076, alaa.saad@dentistry.cu.edu.eg
Passant Nagi, 00201280557107, passant.nagi@dentistry.cu.edu.eg
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Soft Tissue Injuries
- Being tested
- OraVerse
- Keywords
- lip biting hematoma
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraVerseDrug
Also called phentolamine mesylate
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.
| Study group | Role | What they receive |
|---|---|---|
| participants receiving oraverse injection after local anaesthetic administration | Experimental | 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. Receives: Drug: OraVerse |
| participants with no drug after local anaesthetic administration | No intervention | participants don't receive any reversal agent or placebo after the completion of their dental procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: the following 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start5 Jul 2025
- Primary completion20 Apr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InjuriesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group: they 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. Control group: they don't receive any reversal agent or placebo after the completion of their dental procedures.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Saad Abourawash Tolba, Cairo University
- Investigators
- mahmoud hamdy, professor, Study chair, main supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448807
- Sponsor's protocol ID
- 71192
- Status last verified
- Jul 2025
- First submitted
- 29 Jun 2022
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05448807
- Acronym / sponsor ID
- 71192
- Conditions
- Soft Tissue Injuries
- Keywords
- lip biting hematoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group: they 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. Control group: they don't receive any reversal agent or placebo after the completion of their dental procedures.
| Arm | Type | Receives |
|---|---|---|
| participants receiving oraverse injection after local anaesthetic administration | Experimental | Drug: OraVerseparticipants 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. |
| participants with no drug after local anaesthetic administration | No intervention | –participants don't receive any reversal agent or placebo after the completion of their dental procedures. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OraVerseAlso: phentolamine mesylatePhentolamine 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. | Drug | participants receiving oraverse injection after local anaesthetic administration |
Primary outcome
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
3 secondary outcomes
Incidence of self-inflicted soft tissue trauma
Time frame: 2 hours
Cost effectiveness of oraverse
Time frame: Through the completion of the study, with average 1 year
post-operative pain by 170 mm Heft-parker visual analogue scale (VAS)
Time frame: the following 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
mahmoud hamdy, professor study chair
main supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OraVerse in people with Soft Tissue Injuries, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact alaa saad abourawash (01144942076, alaa.saad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to return to normal function (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.