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Completed

NCT Number: NCT05443009

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

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.

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Key information

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro de Especialidades Odontológicas (CEO), Florianópolis, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

A buccal infiltration injection followed by palatal injections and interpapillary injections of 2% lidocaine with 1:100,000 epinephrine will be administered.

Other names: Control Grup

Articaine

Drug

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

Other names: Test Grup

Primary outcomes

  1. Dental Pain

    Time frame: Immediately after the maxillary primary molar extraction

    Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome)

Other outcomes

  1. Dental Pain

    Time frame: During the injection of local anesthesia and the surgical procedure

    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)

  2. Dental Pain

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

    Self-assessment of pain using the Wong-Baker FACES Pain Rating Scale (FACES 0-10 score, higher values represent a worse outcome)

  3. Dental Pain

    Time frame: Immediately after the injection of local anesthesia

    Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome)

  4. Heart rate variability

    Time frame: Immediately before, durin, and immediately after the surgical procedure

    Heart rate variability to be verified and recorded with the heart rate sensor (Polar H-10)

  5. Heart rate

    Time frame: Immediately before, durin, and immediately after the surgical procedure

    Heart rate to be verified and recorded at moments described above carried out with the heart rate sensor (Polar H-10) and pulse oximeter

  6. Evaluation of Post-surgical Pain

    Time frame: 24 hours after the surgical procedure

    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

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Catarina

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2022
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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