Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH

Study Overview
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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

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.

Official Title
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A Comparison the Effectiveness of Anesthesia With Lidocaine 2% or Articaine 4% in Children With Molar Incisor Hypomineralisation (MIH)

Conditions
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Molar Incisor Hypomineralisation

Intervention / Treatment
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* Drug: Lidocaine 2%
* Drug: Articaine 4%


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomized, controlled, crossover, double-blind clinical study, Comparison of articaine 4% and lidocaine 2%
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: : A (Lidocaine 2%)<br>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 | Drug: Lidocaine 2%<br>* 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<br>* Other names: A;|
| Experimental: B (Articaine 4%)<br>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 | Drug: Articaine 4%<br>* 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<br>* Other names: B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dental pain | evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain).. | during the injection of local anesthesia | 
| dental pain | self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or no hurt, to a crying face at 10,which represents hurts like the worst pain imaginable ) | Immediately after the injection of local anesthesia | 
| dental pain | evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain).. | during treatment | 
| dental pain | self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or no hurt, to a crying face at 10,which represents hurts like the worst pain imaginable ) | Immediately after the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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the local anesthesia, Lidocaine 2%, Articaine 4%, children, MIH molars.