Oraverse Versus Laser | NCT05473858

Studies
Oraverse Versus Laser

NCT05473858

Sponsor

sara nabil

Status

Recruiting

Last Update Posted

Apr 6, 2026Actual

Enrollment

36Estimated

Phase

Phase 3

Conditions

Reversal of Local Anesthesia in Children

Interventions

OraVerse Injectable Product
diode laser
Anaesthesia only

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2021Actual

Primary Completion Date

Apr 10, 2026Estimated

Completion Date

Apr 10, 2026Estimated

First Submitted Date

Jul 22, 2022

First Submission Date that Met QC Criteria

Jul 22, 2022

First Posted Date

Jul 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
Control group	Experimental	Patient exposed to anaesthesia only	Other: Anaesthesia only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OraVerse Injectable Product	Drug	injection of oraverse,	oraverse group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 -

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sara nabil, DR	Contact	00201006420998		snhasem@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr.sara nabil	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054023	Lasers, Semiconductor

Ancestor Terms

ID	Term
D007834	Lasers
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided