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NCT05101785 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05101785
Other study ID # 3081
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date November 1, 2022

Study information
Verified date October 2021
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 292
Est. completion date November 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 3 Years to 6 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocain hydrochloride 2 % with epinephrine
Local anesthesia infilteration in children
• Articaine chloride 4% with epinephrine
Articaine chloride 4% with epinephrine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mahmoud Ahmed Mahmoud

Outcome
Type Measure Description Time frame Safety issue
Primary Intra and post operative pain Evaluate pain during injection and treatment using FLACC (face,legs,activity, cry, consolabolity) scale 30-60 minutes
Primary Behavior Evaluate child behavior using frankl scale during treatment 30-60 minutes
Primary Blood pressure Vital signs 30-60 minutes
Primary Heart rate Vital signs 30-60 minutes
Primary Respiratory rate measuring during treatment Vital signs 30-60 minutes
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