Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L in Extraction of Lower First Primary Molars

NCT ID: NCT03942991

Last Updated: 2019-08-29

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-12-01

Brief Summary

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parallel technique will be done where the investigator (will be blinded) will give one type on anesthesia then performing the extraction and evaluating the intraoperative pain ,the same procedure will be done for the other type of anesthesia.

Detailed Description

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Conditions

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Badly Decayed Lower First Primary Molars in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2% Mepecaine-L

infiltration injection of 2% Mepivacaine

Group Type ACTIVE_COMPARATOR

Mepivacaine 2% Injection

Intervention Type DRUG

infiltration injection of 2% Mepecaine-L

4% Artpharmadent

infiltration injection of 4% Articaine

Group Type EXPERIMENTAL

articaine

Intervention Type DRUG

infiltration injection of 4%artpharmadent

Interventions

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articaine

infiltration injection of 4%artpharmadent

Intervention Type DRUG

Mepivacaine 2% Injection

infiltration injection of 2% Mepecaine-L

Intervention Type DRUG

Other Intervention Names

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Artpharmadent 2% Mepecaine-L

Eligibility Criteria

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Inclusion Criteria

* Children aged 6-8 years.
* Medically fit (ASA I, II).
* Mentally capable of communication.
* Having a mandibular first primary molar tooth that require Extraction.
* Child must give assent prior to participation, as well as parental informed written consent.
* Body weight \>20 kg.
* it should be the first dental treatment to the child

Exclusion Criteria

* Medically and mentally compromised children.
* Children without a history of prolonged bleeding, platelet disorders, hypersensitivity,
* History of significant behavior management problems.
* Patients having active sites of pathosis in the area of injection.
* Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
* Patients allergic to Articaine and/or Mepivacaine and/or sulfur
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nadeen Hossam Eldin Hosny Ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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14422017496941

Identifier Type: -

Identifier Source: org_study_id

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