NCT05101785

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
292

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

October 28, 2021

Last Update Submit

October 29, 2021

Conditions

PainBehavior

Outcome Measures

Primary Outcomes (5)

  • Intra and post operative pain

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

    30-60 minutes

  • Behavior

    Evaluate child behavior using frankl scale during treatment

    30-60 minutes

  • Blood pressure

    Vital signs

    30-60 minutes

  • Heart rate

    Vital signs

    30-60 minutes

  • Respiratory rate measuring during treatment

    Vital signs

    30-60 minutes

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Lidocain hydrochloride 2 %with epinephrine 1:100000

Drug: Lidocain hydrochloride 2 % with epinephrine

Articaine

EXPERIMENTAL

Articaine chloride 4% with epinephrine 1:100000

Drug: Articaine chloride 4% with epinephrine

Interventions

Lidocain hydrochloride 2 % with epinephrineDRUG

Local anesthesia infilteration in children

Lidocaine
Articaine chloride 4% with epinephrineDRUG

Articaine chloride 4% with epinephrine

Articaine

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainBehavior

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 1, 2021

Study Start

November 1, 2021

Primary Completion

September 1, 2022

Study Completion

November 1, 2022

Last Updated

November 1, 2021

Record last verified: 2021-10