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

NCT05944341 | Unknown

• 1 other identifier: 778
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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)

Conditions

Dental Pulp Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

articaine hydrochloride 4% with epinephrine 1:100 000 DRUG

Local anesthetic agent

Articaine; Lidocaine

Lidocaine hydrochloride 2% with epinephrine 1:100 000 DRUG

Local anesthetic agent

Articaine; Lidocaine

Eligibility Criteria

• Age: 36 Months - 47 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Ahmad Elheeny

Minya, Minya Governorate, 61111, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Carticaine; Epinephrine; Lidocaine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 13, 2023
• Study Start: June 1, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

EG (1)