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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05101785
Enrollment
292
Registered
2021-11-01
Start date
2021-11-01
Completion date
2022-11-01
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Pain

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.

Interventions

DRUGLidocain hydrochloride 2 % with epinephrine

Local anesthesia infilteration in children

DRUGArticaine chloride 4% with epinephrine

Articaine chloride 4% with epinephrine

Sponsors

Mahmoud Ahmed Mahmoud
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intra and post operative pain30-60 minutesEvaluate pain during injection and treatment using FLACC (face,legs,activity, cry, consolabolity) scale
Behavior30-60 minutesEvaluate child behavior using frankl scale during treatment
Blood pressure30-60 minutesVital signs
Heart rate30-60 minutesVital signs
Respiratory rate measuring during treatment30-60 minutesVital signs

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026