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

NCT05443009 | Completed Phase 4

• 1 other identifier: 030422
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Dental Pain; Anesthesia, Local

Keywords

articaine; lidocaine; child; pain

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (6)

• Dental Pain

  During the injection of local anesthesia and the surgical procedure

• Dental Pain

  Immediately after the injection of local anesthesia and the maxillary primary molar extraction

• Dental Pain

  Immediately after the injection of local anesthesia

Study Arms (2)

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

Drug: Lidocaine

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

Drug: Articaine

Interventions

Lidocaine DRUG

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

Lidocaine

Articaine DRUG

A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered.

Also known as: Test Grup

Articaine

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

Study Sites (4)

Centro de Especialidades Odontológicas (CEO)

Florianópolis, Brazil

Location

Centro de Especialidades Odontológicas (CEO)

Palhoça, Brazil

Location

Universidade Federal de Santa Catarina - USFC

Santa Catarina, Brazil

Location

Centro de Especialidades Odontológicas (CEO)

São José, Brazil

Location

Related Publications (3)

• 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.

  PMID: 32934983 BACKGROUND

• 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.

  PMID: 32847666 BACKGROUND

• 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.

  PMID: 40932429 DERIVED

MeSH Terms

Conditions

Toothache; Pain

Interventions

Lidocaine; Carticaine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mariane Cardoso, PhD

  Universidade Federal de Santa Catarina - UFSC

  STUDY DIRECTOR

• Carla Santana, PhD

  Universidade Federal de Santa Catarina - UFSC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: June 30, 2022
• Primary Completion: July 4, 2024
• Study Completion: November 21, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (4)