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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443009
• Other study ID #: 030422
• Status: Recruiting
• Phase: Phase 4
• Start date: June 30, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Universidade Federal de Santa Catarina
• Contact: Danielle Rigo, MSc.
• Phone: +5548998299559
• Email: dani-riggo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Dental Pain
• Toothache

Intervention

Drug:
• Lidocaine
A buccal infiltration injection followed by palatal injections and interpapillary injections of 2% lidocaine with 1:100,000 epinephrine will be administered.
• Articaine
A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered.

Locations

Country	Name	City	State
Brazil	Centro de Especialidades Odontológicas (CEO)	Florianópolis
Brazil	Centro de Especialidades Odontológicas (CEO)	Palhoça
Brazil	Universidade Federal de Santa Catarina - USFC	Santa Catarina
Brazil	Centro de Especialidades Odontológicas (CEO)	São José

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Catarina

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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