Articaine 4% Versus Lidocaine 2% for Local Anesthesia of MIH-affected Maxillary Molars

NCT ID: NCT05585112

Last Updated: 2023-05-03

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2022-12-25

Brief Summary

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Comparison of injection pain with lidocaine and articaine. Comparison of the efficacy of lidocaine and articaine during treatment of MIH- maxillary molars.

Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children, aged 6-12years old

Detailed Description

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Background and Aims: Some dentists have difficulty obtaining effective anesthesia when treating MIH molars.

There are no studies comparing the effectiveness of lidocaine and articaine in MIH-maxillary molars.

Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children , aged 6-12 years old. Each child was randomly assigned to either articaine 4% or lidocaine 2% in their first session with the second solution being used at the second session.

Conditions

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Molar Incisor Hypomineralisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A randomized, controlled, crossover, Triple-blinding clinical study, Comparison of articaine 4% and lidocaine 2%
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
as neither the child/parent, the investigator who performed the anesthesia/treatment, nor the assessors were aware of the type of anesthetic solution in order to avoid bias towards one of the solutions

Study Groups

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A (Lidocaine 2%)

26 children will be injected with 1 ml of lidocaine 2% with epinephrine

Group Type ACTIVE_COMPARATOR

Lidocaine 2%

Intervention Type DRUG

The child will be injected with lidocaine 2%,after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and pain after injection and treatment will be evaluated using the Wong-Baker faces pain rating scale

B (Articaine 4%)

26 children will be injected with 1 ml of Articaine 4% with epinephrine.

Group Type EXPERIMENTAL

Articaine 4%

Intervention Type DRUG

The child will be injected with 4% Articaine, after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and Wong-Baker faces pain rating scale

Interventions

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Lidocaine 2%

The child will be injected with lidocaine 2%,after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and pain after injection and treatment will be evaluated using the Wong-Baker faces pain rating scale

Intervention Type DRUG

Articaine 4%

The child will be injected with 4% Articaine, after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and Wong-Baker faces pain rating scale

Intervention Type DRUG

Other Intervention Names

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A B

Eligibility Criteria

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Inclusion Criteria

* Absolute positive or positive behavior according to the Frankel Scale.
* child is not under the effect of any analgesics or sedatives and their weight was more than 20 kg.
* Healthy, both physically and mentally
* A child with a MIH-affected maxillary permanent first molar on the right and left sides .

Exclusion Criteria

* children who are uncooperative
* allergic anesthetics used in the study
* children who show inflammation in the injection site.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tishreen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nabih Raslan, Dr

Role: STUDY_CHAIR

Tishreen University

Mai Haidar, Dr

Role: PRINCIPAL_INVESTIGATOR

Tishreen University

Locations

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Tishreen University

Latakia, , Syria

Site Status

Countries

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Syria

Other Identifiers

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Tishreen U _Local anesthesia

Identifier Type: -

Identifier Source: org_study_id

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