Articaine Efficacy and Safety for Children Below Age of 4... | NCT04061265

Studies
Articaine Efficacy and Safety for Children Below Age of 4-years

NCT04061265

Sponsor

Minia University

Status

Completed

Last Update Posted

Feb 17, 2020Actual

Enrollment

184Actual

Phase

Phase 1Phase 2

Conditions

Behaviour Assessment
Pain

Interventions

Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml
lidocaine hydrochloride 2% and epinephrine 1:100000

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 25, 2019Actual

Primary Completion Date

Jan 15, 2020Actual

Completion Date

Jan 15, 2020Actual

First Submitted Date

Aug 15, 2019

First Submission Date that Met QC Criteria

Aug 16, 2019

First Posted Date

Aug 19, 2019Actual

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

Feb 12, 2020

Last Update Posted Date

Feb 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmad Elheeny, Lecturer of Pediatri, Faculty of Dentistry, Minia University, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.

Detailed Description

Not provided

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

184Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lidocaine 2% group	Active Comparator	lidocaine hydrochloride 2% and epinephrine 1:100000 (Lignospan® standard, 1.7ml, SEPTODONT Ltd)	Drug: lidocaine hydrochloride 2% and epinephrine 1:100000
Articaine 4%	Experimental	articaine hydrochloride 4% and epinephrine 1:100000 (Septocaine® 1.7ml, SEPTODONT Ltd)	Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml	Drug	Local anesthetic agent	Articaine 4%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain assessment	FLACC scale	During the procedures
Behavior	Frankl behaviour scale	before and after the procedures

Secondary Outcomes

Measure	Description	Time Frame
postoperative complications	Asking parents/caregiver in the next 24 hours using Parents' postoperative pain measure (PPPM)	24 hours after the procedures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.

Exclusion Criteria:

The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

37 Months

Maximum Age

47 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmad Elheeny	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ngwa Khattab		Minya	Minya Governorate	61111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002355	Carticaine
D004837	Epinephrine
D008012	Lidocaine

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided