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

NCT ID: NCT05944341

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-07-15

Brief Summary

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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

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Conditions

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Dental Pulp Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Articaine

Group Type EXPERIMENTAL

articaine hydrochloride 4% with epinephrine 1:100 000

Intervention Type DRUG

Local anesthetic agent

Lidocaine hydrochloride 2% with epinephrine 1:100 000

Intervention Type DRUG

Local anesthetic agent

Lidocaine

Group Type ACTIVE_COMPARATOR

articaine hydrochloride 4% with epinephrine 1:100 000

Intervention Type DRUG

Local anesthetic agent

Lidocaine hydrochloride 2% with epinephrine 1:100 000

Intervention Type DRUG

Local anesthetic agent

Interventions

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articaine hydrochloride 4% with epinephrine 1:100 000

Local anesthetic agent

Intervention Type DRUG

Lidocaine hydrochloride 2% with epinephrine 1:100 000

Local anesthetic agent

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

36 Months

Maximum Eligible Age

47 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Elheeny

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmad Elheeny

Minya, Minya Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Ahmad Elheeny, PhD

Role: primary

00201064257135

Other Identifiers

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778

Identifier Type: -

Identifier Source: org_study_id

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