Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years

Not Applicable

• Conditions: Pain; Behavior
• Interventions: Drug: Lidocain hydrochloride 2 % with epinephrine; Drug: Articaine chloride 4% with epinephrine

• Registration Number: NCT05101785
• Lead Sponsor: Mahmoud Ahmed Mahmoud

Brief Summary

compare the anaesthetic efficacy and safety for pain and behaviour for extraction or pulp therapy in primary molars in young children below four years old using 4% articaine and 2% lidocaine local anesthetics.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-29
• Last Update Submitted: 2021-10-29
• Study Start: 2021-11-01
• Study First Posted: 2021-11-01
• Last Update Posted: 2021-11-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

• Healthy children
• 3-6 years
• primary molar indicated for pulpotomy
• body weight not less than 15 Kg

Exclusion Criteria

• Intellectual problem
• sever emotional problems
• previous dental experience
• Medically or mentally compromised children

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocain hydrochloride 2 % with epinephrine	Lidocain hydrochloride 2 %with epinephrine 1:100000
Articaine	Articaine chloride 4% with epinephrine	Articaine chloride 4% with epinephrine 1:100000

Primary Outcome Measures

Name	Time	Method
Behavior	30-60 minutes	Evaluate child behavior using frankl scale during treatment
Blood pressure	30-60 minutes	Vital signs
Heart rate	30-60 minutes	Vital signs
Intra and post operative pain	30-60 minutes	Evaluate pain during injection and treatment using FLACC (face,legs,activity, cry, consolabolity) scale
Respiratory rate measuring during treatment	30-60 minutes	Vital signs