Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-22

Study Completion Date

2022-06-10

Brief Summary

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Aims: Comparison of injection pain with lidocaine and articaine in children with MIH .

Comparison of the efficacy of lidocaine and articaine during treatment of MIH molars.

Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children, aged 6-12years old

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Detailed Description

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Background and Aims: Effectively achieving anesthesia is one of the difficulties a dentist faces when treating MIH molar There are no studies comparing the effectiveness of lidocaine and articaine in MIH molar Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children , aged 6-12 years old Each child will receive either lidocaine or articaine at their ﬁrst or second visit.

Conditions

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Molar Incisor Hypomineralisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A randomized, controlled, crossover, double-blind clinical study, Comparison of articaine 4% and lidocaine 2%

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.

Study Groups

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: A (Lidocaine 2%)

20 children will be injected with 1 ml of lidocaine 2% with epinephrine. each one received lidocaine2% at his\\her ﬁrst or second visit.

Half of the total number of injections for 20 children i.e. 20 injections will be distributed randomly to the two drugs using the randomization table

Group Type ACTIVE_COMPARATOR

Lidocaine 2%

Intervention Type DRUG

The child will be injected with lidocaine 2% and After 10 minutes 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%)

20 children will be injected with 1 ml of Articaine 4% with epinephrine. each one received articaine 4% at his\\her ﬁrst or second visit.

Half of the total number of injections for 20 children i.e.20 injections will be distributed randomly to the two drugs using the randomization table

Group Type EXPERIMENTAL

Articaine 4%

Intervention Type DRUG

The child will be injected with 4% Articaine and After 10 minutes the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and face scale

Interventions

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Lidocaine 2%

The child will be injected with lidocaine 2% and After 10 minutes 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 and After 10 minutes the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and face 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.
* Healthy, both physically and mentally.
* Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment.
* A child with a MIH-affected mandibular permanent first molar on the right and left sides .

Exclusion Criteria

* Teeth with non-response pulpitis Inflammation at the injection site.
* Allergy to the substances used in anesthesia.
* Presence of general or developmental medical conditions.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes