Reversal of Local Anesthesia in ChildrenPhase 3RCTNCT05473858
Phentolamine Mesylate vs. Diode Laser for Anaesthesia Reversal
A Phase 3 study testing OraVerse Injectable Product and diode laser in people with Reversal of Local Anesthesia in Children, run by sara nabil at 1 site in Egypt.
Trial summary
"Randomised three-arm trial comparing phentolamine mesylate (OraVerse), 650-nm diode laser and no intervention for accelerating reversal of soft-tissue anaesthesia after 4% articaine (1:100,000 epinephrine) buccal infiltration in children aged 8-10 years. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversal of Local Anesthesia in Children
- What is being tested?
- OraVerse Injectable Product and diode laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2025to 10 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who need to be treated under anesthesia by injecting mandibular first molar infiltration.
- Cooperative children aged 8 to 10 years old with the ability to understand and respond to the sensation of soft tissue -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phentolamine Mesylate vs. Diode Laser for Accelerating Soft-Tissue Anesthesia Reversal in Children: A Randomized Clinical Trial
"Randomised three-arm trial comparing phentolamine mesylate (OraVerse), 650-nm diode laser and no intervention for accelerating reversal of soft-tissue anaesthesia after 4% articaine (1:100,000 epinephrine) buccal infiltration in children aged 8-10 years.
Read the detailed description
Conducted design: 36 children aged 8-10 years requiring extraction of a mandibular first primary molar received 1.4 mL of 4% articaine with 1:100,000 epinephrine by buccal infiltration and were randomised 1:1:1 to three parallel groups (n = 12 each). Twenty minutes after injection: (1) Control - no intervention; (2) OraVerse - phentolamine mesylate 1.4 mL at the same site and technique; (3) Laser - 650-nm diode laser at seven points (4 intraoral, 3 extraoral), 25 s per point, total energy 12.5 J. The outcome assessor was blinded to group allocation; participants and operators could not be blinded. Lip numbness was assessed until full recovery.
- Conditions
- Reversal of Local Anesthesia in Children
- Being tested
- OraVerse Injectable Product, diode laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraVerse Injectable ProductDrug
injection of oraverse,
diode laserDevice
patient exposed to diode laser
| Study group | Role | What they receive |
|---|---|---|
| laser group | Experimental | "650-nm diode laser (LX16Plus, Woodpecker), 7 points (4 intraoral, 3 extraoral), 25 s per point, 50 mW intraoral / 100 mW extraoral, total energy 12.5 J, applied 20 minutes after injection." 12 Arms → OraVerse group "injection of oraverse," No dose or timing. Receives: Device: diode laser |
| oraverse group | Experimental | "Phentolamine mesylate (OraVerse) 1.4 mL injected at the anaesthetic injection site, same technique, 20 minutes after injection Receives: Drug: OraVerse Injectable Product |
| Control group | No intervention | Articane infiltration only; no reversal intervention." 11 Arms → Laser group "patient exposed to diode laser" No laser parameters or timing. Arm type: Experimental. In |
What is being measured
The primary outcome is the main question the study is designed to answer.
reversal of local anasthesia
patient free of lip numbness
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start10 Aug 2025
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversal of Local Anesthesia in ChildrenStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- sara nabil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sara nabil, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473858
- Sponsor's protocol ID
- AlAzhar
- Acronym
- RCT
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phentolamine Mesylate vs. Diode Laser for Accelerating Soft-Tissue Anesthesia Reversal in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05473858
- Acronym / sponsor ID
- RCT / AlAzhar
- Conditions
- Reversal of Local Anesthesia in Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- sara nabilUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 26 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.
"Randomised three-arm trial comparing phentolamine mesylate (OraVerse), 650-nm diode laser and no intervention for accelerating reversal of soft-tissue anaesthesia after 4% articaine (1:100,000 epinephrine) buccal infiltration in children aged 8-10 years.
Detailed description
Conducted design: 36 children aged 8-10 years requiring extraction of a mandibular first primary molar received 1.4 mL of 4% articaine with 1:100,000 epinephrine by buccal infiltration and were randomised 1:1:1 to three parallel groups (n = 12 each). Twenty minutes after injection: (1) Control - no intervention; (2) OraVerse - phentolamine mesylate 1.4 mL at the same site and technique; (3) Laser - 650-nm diode laser at seven points (4 intraoral, 3 extraoral), 25 s per point, total energy 12.5 J. The outcome assessor was blinded to group allocation; participants and operators could not be blinded. Lip numbness was assessed until full recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laser group | Experimental | Device: diode laser"650-nm diode laser (LX16Plus, Woodpecker), 7 points (4 intraoral, 3 extraoral), 25 s per point, 50 mW intraoral / 100 mW extraoral, total energy 12.5 J, applied 20 minutes after injection." 12 Arms → OraVerse group "injection of oraverse," No dose or timing. |
| oraverse group | Experimental | Drug: OraVerse Injectable Product"Phentolamine mesylate (OraVerse) 1.4 mL injected at the anaesthetic injection site, same technique, 20 minutes after injection |
| Control group | No intervention | –Articane infiltration only; no reversal intervention." 11 Arms → Laser group "patient exposed to diode laser" No laser parameters or timing. Arm type: Experimental. In |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients who need to be treated under anesthesia by injecting mandibular first molar infiltration.
- Cooperative children aged 8 to 10 years old with the ability to understand and respond to the sensation of soft tissue -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OraVerse Injectable Productinjection of oraverse, | Drug | oraverse group |
| diode laserpatient exposed to diode laser | Device | laser group |
Primary outcome
reversal of local anasthesia
Time frame: 30 minute
patient free of lip numbness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Injectable Product and diode laser in people with Reversal of Local Anesthesia in Children, run by sara nabil 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 2 inclusion and 0 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: finished, as of the sponsor's last update on 16 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reversal of local anasthesia (time frame: 30 minute). 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 16 Oct 2026.