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

NCT ID: NCT05101785

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-11-01

Brief Summary

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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

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Conditions

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Pain Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Lidocaine

Lidocain hydrochloride 2 %with epinephrine 1:100000

Group Type ACTIVE_COMPARATOR

Lidocain hydrochloride 2 % with epinephrine

Intervention Type DRUG

Local anesthesia infilteration in children

Articaine

Articaine chloride 4% with epinephrine 1:100000

Group Type EXPERIMENTAL

Articaine chloride 4% with epinephrine

Intervention Type DRUG

Articaine chloride 4% with epinephrine

Interventions

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Lidocain hydrochloride 2 % with epinephrine

Local anesthesia infilteration in children

Intervention Type DRUG

Articaine chloride 4% with epinephrine

Articaine chloride 4% with epinephrine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahmoud Ahmed Mahmoud

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Ahmed Mahmoud

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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3081

Identifier Type: -

Identifier Source: org_study_id