Clinical trial NCT05443009: Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction
Official title: Evaluation of Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Pain
Anesthesia, Local
Keywords: articaine
lidocaine
child
pain
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A blind, controlled, randomized, non-inferiority clinical trial with two parallel groups with allocation ratio will be 1:1
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dental Pain
timeFrame: Immediately after the maxillary primary molar extraction
Secondary outcomes:
Other outcomes:
measure: Dental Pain
timeFrame: During the injection of local anesthesia and the surgical procedure
measure: Dental Pain
timeFrame: Immediately after the injection of local anesthesia and the maxillary primary molar extraction
measure: Dental Pain
timeFrame: Immediately after the injection of local anesthesia
measure: Heart rate variability
timeFrame: Immediately before, durin, and immediately after the surgical procedure
measure: Heart rate
timeFrame: Immediately before, durin, and immediately after the surgical procedure
measure: Evaluation of Post-surgical Pain
timeFrame: 24 hours after the surgical procedure
Locations:
city: Florianópolis
country: Brazil
facility: Centro de Especialidades Odontológicas (CEO)
city: Palhoça
country: Brazil
facility: Centro de Especialidades Odontológicas (CEO)
city: Santa Catarina
country: Brazil
facility: Universidade Federal de Santa Catarina - USFC
city: São José
country: Brazil
facility: Centro de Especialidades Odontológicas (CEO)
Study officials:
affiliation: Universidade Federal de Santa Catarina - UFSC
name: Mariane Cardoso, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Santa Catarina - UFSC
name: Carla Santana, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.