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Clinical Trials/NCT05101785
NCT05101785
Unknown
Not Applicable

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

Mahmoud Ahmed Mahmoud0 sites292 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Lidocain hydrochloride 2 % with epinephrine
Conditions
Pain
Sponsor
Mahmoud Ahmed Mahmoud
Enrollment
292
Primary Endpoint
Behavior
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
November 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mahmoud Ahmed Mahmoud
Responsible Party
Sponsor Investigator
Principal Investigator

Mahmoud Ahmed Mahmoud

Lecturer

Minia University

Eligibility Criteria

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

Arms & Interventions

Lidocaine

Lidocain hydrochloride 2 %with epinephrine 1:100000

Intervention: Lidocain hydrochloride 2 % with epinephrine

Articaine

Articaine chloride 4% with epinephrine 1:100000

Intervention: Articaine chloride 4% with epinephrine

Outcomes

Primary Outcomes

Behavior

Time Frame: 30-60 minutes

Evaluate child behavior using frankl scale during treatment

Blood pressure

Time Frame: 30-60 minutes

Vital signs

Heart rate

Time Frame: 30-60 minutes

Vital signs

Intra and post operative pain

Time Frame: 30-60 minutes

Evaluate pain during injection and treatment using FLACC (face,legs,activity, cry, consolabolity) scale

Respiratory rate measuring during treatment

Time Frame: 30-60 minutes

Vital signs

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