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

Primary Purpose

Dental Pulp Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
articaine hydrochloride 4% with epinephrine 1:100 000
Lidocaine hydrochloride 2% with epinephrine 1:100 000
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Pulp Diseases

Eligibility Criteria

36 Months - 47 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ahmad ElheenyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Articaine

Lidocaine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 23, 2023
Last Updated
July 5, 2023
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT05944341
Brief Title
Articaine Efficiency in Pulpectomy of Children With Irreversible Pulpitis Under the Age of Four
Official Title
Articaine Success in Pulpectomy of Primary Molars With Irreversible Pulpitis in Children Under Four Years: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
July 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Articaine
Arm Type
Experimental
Arm Title
Lidocaine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
articaine hydrochloride 4% with epinephrine 1:100 000
Intervention Description
Local anesthetic agent
Intervention Type
Drug
Intervention Name(s)
Lidocaine hydrochloride 2% with epinephrine 1:100 000
Intervention Description
Local anesthetic agent
Primary Outcome Measure Information:
Title
Face, Legs, Activity, Cry, Consolability pain scale
Description
its scores range from None/mild pain scores 0-3 Moderate pain scores 4-6 Severe pain scores 7-10
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Ahmad Elheeny
City
Al Minyā
State/Province
Al Minya
ZIP/Postal Code
61111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Elheeny, PhD
Phone
00201064257135
Email
ahmedelheeny@mu.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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