A Phase 4 interventional study of Lidocaine and Articaine in Dental Pain and Anesthesia, Local, sponsored by Universidade Federal de Santa Catarina. Completed at 4 sites in Brazil. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Universidade Federal de Santa Catarina · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Thirty-eight (38) 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
Thirty-eightt (38) 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
A buccal infiltration injection followed by palatal injections and interpapillary injections of 2% lidocaine with 1:100,000 epinephrine will be administered.
Also known as: Control Grup
A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered.
Also known as: Test Grup
Dental Pain
Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome)
Time frame: Immediately after the maxillary primary molar extraction
Dental Pain
Pain is evaluated by the outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (FLACC 0-10 score, higher values represent a worse outcome) and the Faces Pain Scale - Revised (FBRS 0-10 score, higher values represent a worse outcome)
Time frame: During the injection of local anesthesia and the surgical procedure
Dental Pain
Self-assessment of pain using the Wong-Baker FACES Pain Rating Scale (FACES 0-10 score, higher values represent a worse outcome)
Time frame: Immediately after the injection of local anesthesia and the maxillary primary molar extraction
Dental Pain
Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome)
Time frame: Immediately after the injection of local anesthesia
Heart rate variability
Heart rate variability to be verified and recorded with the heart rate sensor (Polar H-10)
Time frame: Immediately before, durin, and immediately after the surgical procedure
Heart rate
Heart rate to be verified and recorded at moments described above carried out with the heart rate sensor (Polar H-10) and pulse oximeter
Time frame: Immediately before, durin, and immediately after the surgical procedure
Evaluation of Post-surgical Pain
Self-assessment of pain using a Visual Analogue Scale (VAS 0-100 mm, higher values represent a worse outcome) and the Faces Pain Scale - Revised (FBRS 0-10 score, higher values represent a worse outcome) in the postoperative period. It will be applied through teleconsultation
Time frame: 24 hours after the surgical procedure
Plan to share: No
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Universidade Federal de Santa Catarina