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

M

Minia University

Status

Enrolling

Conditions

Dental Pulp Diseases

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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)

Enrollment

164 estimated patients

Sex

All

Ages

36 to 47 months old

Volunteers

Accepts 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

164 participants in 2 patient groups

Articaine
Experimental group
Treatment:
Drug: articaine hydrochloride 4% with epinephrine 1:100 000
Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000
Lidocaine
Active Comparator group
Treatment:
Drug: articaine hydrochloride 4% with epinephrine 1:100 000
Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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