Articaine Efficiency in Pulpectomy of Children With Irrev... | NCT05944341

Studies
Articaine Efficiency in Pulpectomy of Children With Irreversible Pulpitis Under the Age of Four

NCT05944341

Sponsor

Minia University

Status

Unknown status

Last Update Posted

Jul 13, 2023Actual

Enrollment

164Estimated

Phase

Not Applicable

Conditions

Dental Pulp Diseases

Interventions

articaine hydrochloride 4% with epinephrine 1:100 000
Lidocaine hydrochloride 2% with epinephrine 1:100 000

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Jul 15, 2023Estimated

Completion Date

Jul 15, 2023Estimated

First Submitted Date

Jun 23, 2023

First Submission Date that Met QC Criteria

Jul 5, 2023

First Posted Date

Jul 13, 2023Actual

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

Jul 5, 2023

Last Update Posted Date

Jul 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

A two-tailed randomized controlled trial with two parallel arms is aimed to compare success proportions of the articaine and lidocaine groups in children with irreversible pulpitis under 4 years. The participants will be randomly assigned into two equal groups (82 children per group): the control group will receive lidocaine and the intervention group will receive the articaine local anesthesia.

The direct observation tool FLACC was considered to assess pain severity. The behavior was assessed during pulpectomy procedures using the Frankl behavior rating scale (FBRS)

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

164Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Articaine	Experimental		Drug: articaine hydrochloride 4% with epinephrine 1:100 000 Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000
Lidocaine	Active Comparator		Drug: articaine hydrochloride 4% with epinephrine 1:100 000 Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000

Interventions

Name	Type	Description	Arm Group Labels	Other Names
articaine hydrochloride 4% with epinephrine 1:100 000	Drug	Local anesthetic agent	Articaine Lidocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Face, Legs, Activity, Cry, Consolability pain scale	its scores range from None/mild pain scores 0-3 Moderate pain scores 4-6 Severe pain scores 7-10	up to 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy 36-47 month-children (ASA class I or II) weighing at least 15 kilograms
Children should be intellectually fit, and cooperative, with no behavior or communication abnormalities
Presence of a carious maxillary or mandibular second primary molars with signs and symptoms of irreversible pulpitis

Exclusion Criteria:

Molars with unrestorable crowns
Molars with necrotic pulps, pathological mobility, gingival swelling or abscess, fistulous or sinus tract, or apical periodontitis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

36 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmad Elheeny	Recruiting	Minya	Minya Governorate	61111	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D003788	Dental Pulp Diseases

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

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