Skip to main content
Clinical Trials/NCT05473858
NCT05473858RecruitingPhase 3

Comparative Study of the Effect of Diode Laser and Oraverse on Reversing the Effect of Articaine 4% Soft Tissue Anasthesia in Children

sara nabil1 site in 1 country36 target enrollmentStarted: December 10, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
reversal of local anasthesia

Study Overview

Brief Summary

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

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
6 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients who need to be treated under anesthesia by injecting mandibular first molar infiltration.
  • Cooperative children aged 6 to 10 years old with the ability to understand and respond to the sensation of soft tissue -

Exclusion Criteria

  • Not provided

Arms & Interventions

laser group

Experimental

Patients will be undergoing anesthesia revision by diode laser

Intervention: diode laser (Device)

Control group

Experimental

Patient exposed to anaesthesia only

Intervention: Anaesthesia only (Other)

oraverse group

Experimental

Patients will be undergoing anesthesia revision by oraverse

Intervention: OraVerse Injectable Product (Drug)

Outcomes

Primary Outcomes

reversal of local anasthesia

Time Frame: 30 minute

patient free of lip numbness

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
sara nabil
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

sara nabil

Lecturer of pediatric dentistry

Al-Azhar University

Study Sites (1)

Loading locations...

Similar Trials