Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | 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 |
|
| Articaine | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | A buccal infiltration injection followed by palatal injections and interpapillary injections of 2% lidocaine with 1:100,000 epinephrine will be administered. |
|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) | During the injection of local anesthesia and the surgical procedure |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mariane Cardoso, PhD | Universidade Federal de Santa Catarina - UFSC | Study Director |
| Carla Santana, PhD | Universidade Federal de Santa Catarina - UFSC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Especialidades Odontológicas (CEO) | Florianópolis | Brazil | ||||
| Centro de Especialidades Odontológicas (CEO) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32934983 | Background | Tirupathi SP, Rajasekhar S. Can single buccal infiltration with 4% articaine induce sufficient analgesia for the extraction of primary molars in children: a systematic literature review. J Dent Anesth Pain Med. 2020 Aug;20(4):179-186. doi: 10.17245/jdapm.2020.20.4.179. Epub 2020 Aug 27. | |
| 32847666 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014098 | Toothache |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D002355 | Carticaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
A blind, controlled, randomized, non-inferiority clinical trial with two parallel groups with allocation ratio will be 1:1
Not provided
Not provided
The evaluator will not know to which group the child belongs (anesthetic to be used), nor will he or she see the label of the anesthetic. He or she will be in the room during the initial anesthetic infiltration. All children will be considered participants in the control group, to conceal the anesthetic to be used. The evaluator will be asked to leave the room for as long as necessary to prevent learning whether or not the child receives an additional anesthetic.
|
| Articaine | Drug | A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered. |
|
|
| Dental Pain | Self-assessment of pain using the Wong-Baker FACES Pain Rating Scale (FACES 0-10 score, higher values represent a worse outcome) | 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) | 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) | 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 | 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 | 24 hours after the surgical procedure |
| Palhoça |
| Brazil |
| Universidade Federal de Santa Catarina - USFC | Santa Catarina | Brazil |
| Centro de Especialidades Odontológicas (CEO) | São José | Brazil |
| Taneja S, Singh A, Jain A. Anesthetic Effectiveness of Articaine and Lidocaine in Pediatric Patients During Dental Procedures: A Systematic Review and Meta-Analysis. Pediatr Dent. 2020 Jul 15;42(4):273-281. |
| 40932429 | Derived | Rigo DCA, Santos PS, Moccelini BS, Rocha AO, Garcia JM, Ramos I, Santana CM, Cardoso M. Self-reported pain after buccal infiltration of articaine vs buccal and palatal infiltration of lidocaine for maxillary primary molar extractions: A noninferiority randomized clinical trial. J Am Dent Assoc. 2025 Nov;156(11):909-919. doi: 10.1016/j.adaj.2025.07.014. Epub 2025 Sep 11. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |