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

Study Overview
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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.

Official Title
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Comparative Study of Articaine 4% Versus Lidocaine 2% in Local Anesthesia and Permanent Maxillary First Molars Affected by 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. 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.

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, Triple-blinding clinical study, Comparison of articaine 4% and lidocaine 2%
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A (Lidocaine 2%)<br>26 children will be injected with 1 ml of lidocaine 2% with epinephrine | Drug: Lidocaine 2%<br>* 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<br>* Other names: A;|
| Experimental: B (Articaine 4%)<br>26 children will be injected with 1 ml of Articaine 4% with epinephrine. | Drug: Articaine 4%<br>* 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<br>* Other names: B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| injection 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 procedure | 
| injection 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 procedure | 
| 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 procedure | 
| 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 treatment procedure | 

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