NCT05473858

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

July 22, 2022

Last Update Submit

July 22, 2022

Conditions

Reversal of Local Anesthesia in Children

Outcome Measures

Primary Outcomes (1)

  • reversal of local anasthesia

    patient free of lip numbness

    30 minute

Study Arms (2)

laser group

EXPERIMENTAL

Patients will be undergoing anesthesia revision by diode laser

Device: diode laser

oraverse group

EXPERIMENTAL

Patients will be undergoing anesthesia revision by oraverse

Drug: OraVerse Injectable Product

Interventions

OraVerse Injectable ProductDRUG

injection of oraverse,

oraverse group
diode laserDEVICE

patient exposed to diode laser

laser group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr.sara nabil

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

sara nabil, DR

CONTACT

00201006420998snhasem@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of pediatric dentistry

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 26, 2022

Study Start

December 10, 2021

Primary Completion

September 10, 2022

Study Completion

October 1, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

EG(1)