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

030422

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.

2022-06-30

2024-12-01

2024-12-01

Recruiting

Early phase I

96

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A blind, controlled, randomized, non-inferiority clinical trial with two parallel groups with allocation ratio will be 1:1', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}

2023-11-29