Assess Intraoperative Pain for Restorative Treatment of Maxillary 1st Permanent Molars Using Artinibsa Versus Artpharma in Children During Infiltration Technique

Study Overview
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Brief Summary
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The aim of this study is to assess Intraoperative pain for restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique.

Detailed Description
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Local anesthesia is very important during dental procedure because it's a temporary loss of sensation which will lead to decrease the pain. Local anesthesia started with discovery of Cocaine in 1860. Followed by developments of Novocaine 1904 and lignocaine in 1942 by Lofgren. It became the gold standard drug compared to other local anesthetic. Later, several new drugs were discovered such as:Bupivacaine, Articaine, Mepivicaine etc. Articaine Hydrochloride (HCL) was available in Germany since 1976. It's the only amide local anesthesia containing ester group in its molecular structure leading to metabolizing of the drug by both plasma esterases and liver microsomal enzymes, the clinical efficacy and advantages of articaine is the duration of its anesthetic effect and its superior diffusion through the bony tissue.

Official Title
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Intraoperative Pain During Restorative Treatment Of Maxillary First Permanent Molars Using Artinibsa Versus Artpharma In Children After Infiltration Technique: A Randomized Clinical Trial

Conditions
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Pain

Intervention / Treatment
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* Other: Artinibsa
* Other: Artpharma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 8-10 years old Mentally capable of communication Cooperative children need restorative treatment Exclusion Criteria: Medically compromised patient Primary teeth requiring pulpotomy or pulpectomy Parent or guardians who refuse participating in the study

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 10 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Artinibsa<br>Powerful local anesthetic with short time for patients who can not tolerate normal doses of vasoconstrictor latency. High lipid solubility gives a better diffusion through the soft tissue and bone being very effective in infiltrative techniques. Duration: Latency time: 2 minutes Each mL contains: 4%Articaine 1:100000. Hydrochloride 40.00 mg, Epinephrine (D.C.I) 0.005 mg tartrate | Other: Artinibsa<br>* local anaesthetic solution with a short latency time. Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.Each ml contains 4%Articaine 1:100000.<br>|
| Experimental: Artpharma<br>Its a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 mg) | Other: Artpharma<br>* Its a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Pain: Wong Baker rating scale | Measuring by using Wong Baker rating scale the measuring unite is :Scale (0-10) including six faces. | During the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of anesthesia | is measuring by using stop watch and the unite is minutes. the unit is : minutes | Immediately after the injection. | 
| The sensation after injection | Evaluating the effect of the anesthesia by checking mucosa using the probe and measuring unite is binary (Yes or No) | Immediately after the injection. | 
| Time of numbness disappear | Time of disappearance of numbness sensation by asking the parent/child and measuring is binary (Yes or No). | 2 hours postoperatively after the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Articaine, Infiltration technique, Restoration primary teeth, Intraoperative pain