Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction

Study Overview
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Brief Summary
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The aim of this study is to analyze the effectiveness of articaine in controlling self-reported pain compared with conventional lidocaine anesthesia in children requiring extraction of deciduous maxillary molars. Only one extraction will be performed on each child. At least two consultations will be necessary to carry out the present controlled, randomized, and blinded study. All participants will be treated by the same dentist. Self-reported pain will be assessed using the Visual Analogue Scale.

Detailed Description
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In the present study, self-reported pain during extraction of a maxillary primary molar with one buccal infiltration anesthesia with articaine will be compared with the conventional technique (buccal infiltration and palatal supplementation) with lidocaine. The study design will be a blind, controlled, randomized, non-inferiority clinical trial with two parallel groups. The anesthetic will be administered according to the weight of the child, using a table with the amount of anesthetic per weight group and the maximum recommended dose as reference. The hypothesis is that articaine, due to its anesthetic properties, is able to anesthetize as well as lidocaine with only one oral infiltration, without the need for additional anesthesia, which may guarantee better participant comfort, less dental anxiety, and less chair time. The use of the Visual Analogue Scale is important to assess the pain perceived by the children and to ensure the reliability of the responses. Participant comfort will be evaluated at each stage of the proposed treatment, and withdrawal from participation will be guaranteed at any time.

Official Title
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Evaluation of Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction: Randomized Controlled Clinical Trial

Conditions
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Dental Pain, Anesthesia, Local

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Articaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical criteria: the presence of coronary destruction precluding restoration or adequate use of absolute isolation for endodontic and restorative procedures; perforation of the pulp chamber floor. Radiographic criteria: deciduous molars with at least one non-resorbed half-length root presenting carious lesions or defective restorations associated with signs or symptoms suggestive of pulp necrosis with endodontic contraindication (periapical or interradicular lesion extending over more than half of the roots or involving the crypt of the permanent successor tooth; the presence of pathologic resorption of more than 1/3 of one or more roots; failure of endodontic treatment with the persistence of periapical or inter-radicular lesion with or without clinical signs and symptoms; internal resorption). Exclusion Criteria: Participants with acute pain or presence of odontogenic infection associated with systemic signs and symptoms and in cases of urgency; History of bleeding or blood clotting problems or taking medications that alter blood clotting prior to the procedure; Hypersensitivity or history of allergy to the drugs used in the research; Asthma; History of liver disease; History of sulfite allergy; Report of post-traumatic stress disorders or recurrent hospitalizations, personality or anxiety disorders, diagnosis of phobias or definite uncooperative behavior; Neurological disorders or communication difficulties; Use of analgesic or anti-inflammatory medications up to 5 hours before the procedure; Parents or guardians unable to be available for follow-up and/or respond to information necessary for the survey within 24 hours of the procedure.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: A blind, controlled, randomized, non-inferiority clinical trial with two parallel groups with allocation ratio will be 1:1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Forty-eight (48) children will receive conventional infiltration anesthesia (buccal infiltration injection followed by complementary injections on the palatal region) with 2% lidocaine and 1:100,000 epinephrine at a dose previously calculated by weight. Two-thirds of the anesthetic will be injected into the buccal area and 1/3 into the palatal area. Other Names: Control Group | Drug: Lidocaine<br>* A buccal infiltration injection followed by palatal injections and interpapillary injections of 2% lidocaine with 1:100,000 epinephrine will be administered.<br>* Other names: Control Grup;|
| Experimental: Articaine<br>Forty-eight (48) children will receive a single buccal infiltration injection with 4% articaine and 1:100,000 epinephrine at a dose previously calculated by weight. Other Names: Test Group | Drug: Articaine<br>* A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered.<br>* Other names: Test Grup;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Pain | Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome) | Immediately after the maxillary primary molar extraction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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articaine, lidocaine, child, pain