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Oraverse Versus Laser (RCT)

S

sara nabil

Status and phase

Enrolling
Phase 3

Conditions

Reversal of Local Anesthesia in Children

Treatments

Device: diode laser
Drug: OraVerse Injectable Product

Study type

Interventional

Funder types

Other

Identifiers

NCT05473858
AlAzhar

Details and patient eligibility

About

clinically assess the reversal of articaine 4% of two different concentration of vasoconcentration soft-tissue local anesthesia in pediatric dentistry using Diode Laser and Oraverse

Full description

Patients will be divided randomly into two groups (20 patients in each group) Group (1): Patients will be undergoing anesthesia revision by diode laser Group (2): Patients will be undergoing anesthesia revision by oraverse. Then each group will be subdivided into 2 subgroups (10 patients each) according to type of local anesthetic agent into:

subgroup 1: Articaine 4% with 1:100000 epinephrin &Subgroup 2: Articaine 4% with 1:200000 epinephrin After 30 min of injection corresponding to approximate time of treatment, the patient in each group will be exposed to the reversal agent which may be diode laser or oraverse.

Enrollment

40 estimated patients

Sex

All

Ages

6 to 10 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and 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 -

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

laser group
Experimental group
Description:
Patients will be undergoing anesthesia revision by diode laser
Treatment:
Device: diode laser
oraverse group
Experimental group
Description:
Patients will be undergoing anesthesia revision by oraverse
Treatment:
Drug: OraVerse Injectable Product

Trial contacts and locations

1

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Central trial contact

sara nabil, DR

Data sourced from clinicaltrials.gov

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