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

Sponsor

Minia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05944341

Collaborator

(none)

164

Enrollment

Location

Arms

1.4

Anticipated Duration (Months)

113.4

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Dental Pulp Diseases	Drug: articaine hydrochloride 4% with epinephrine 1:100 000 Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Articaine Success in Pulpectomy of Primary Molars With Irreversible Pulpitis in Children Under Four Years: a Randomized Controlled Trial

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 15, 2023

Anticipated Study Completion Date :

Jul 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Articaine	Drug: articaine hydrochloride 4% with epinephrine 1:100 000 Local anesthetic agent Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000 Local anesthetic agent
Active Comparator: Lidocaine	Drug: articaine hydrochloride 4% with epinephrine 1:100 000 Local anesthetic agent Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000 Local anesthetic agent

Arm

Intervention/Treatment

Experimental: Articaine

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

Local anesthetic agent

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

Local anesthetic agent

Active Comparator: Lidocaine

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

Local anesthetic agent

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

Local anesthetic agent

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

36 Months to 47 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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