Comparing Oraverse and Diode Laser to Reverse Dental Numbing in Children
Comparative Study of the Effect of Diode Laser and Oraverse on Reversing the Effect of Articaine 4% Soft Tissue Anasthesia in Children
This trial tests whether Oraverse or a diode laser works better to reverse numbness from articaine local anesthesia in children aged 6–10 after a mandibular molar injection.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 6 Years to 10 Years |
| Sex | All |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05473858 on ClinicalTrials.gov |
What this trial studies
Forty cooperative children aged 6–10 who require mandibular first molar infiltration with articaine will be randomized into two main groups of 20 to receive either diode laser or Oraverse for soft-tissue anesthesia reversal. Each main group is further split into two subgroups (10 each) according to the epinephrine concentration used with articaine (1:100,000 versus 1:200,000). Reversal intervention will be applied about 30 minutes after the anesthetic injection, approximating typical treatment time, and outcomes will focus on return of normal soft-tissue sensation. The trial is conducted at a single dental clinic in Cairo under the lead investigator Dr. Sara Nabil.
Who should consider this trial
Good fit: Cooperative children aged 6–10 who need a mandibular first molar infiltration using articaine local anesthesia are ideal candidates.
Not a fit: Children allergic to articaine, epinephrine, or phentolamine (Oraverse), those who received a different anesthetic technique, or who cannot cooperate are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could shorten the time children have numb lips or tongues after dental work and reduce accidental biting and discomfort.
How similar studies have performed: Phentolamine mesylate (Oraverse) has prior clinical evidence for speeding recovery of soft-tissue anesthesia, while diode laser use for anesthesia reversal is novel with limited published data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who need to be treated under anesthesia by injecting mandibular first molar infiltration. 2. Cooperative children aged 6 to 10 years old with the ability to understand and respond to the sensation of soft tissue -
Where this trial is running
Cairo
- Dr.sara nabil — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: sara nabil, DR
- Email: snhasem@gmail.com
- Phone: 00201006420998
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.