Oraverse Versus Laser (RCT)

March 31, 2026 updated by: sara nabil

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laser group
Patients will be undergoing anesthesia revision by diode laser
Device: diode laser
patient exposed to diode laser
Experimental: oraverse group
Patients will be undergoing anesthesia revision by oraverse
Drug: OraVerse Injectable Product
injection of oraverse,
Experimental: Control group
Patient exposed to anaesthesia only
Other: Anaesthesia only
Patient exposed to anaesthesia without any more intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reversal of local anasthesia
Time Frame: 30 minute
patient free of lip numbness
30 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

sara nabil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Estimated)

April 10, 2026

Study Completion (Estimated)

April 10, 2026

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

July 22, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlAzhar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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