Danielle Cristina Alves Rigo, Pablo Silveira Santos, Bárbara Suelen Moccelini, Aurélio de Oliveira Rocha, Julia Maldonado Garcia, Isabela Ramos, Carla Miranda Santana, Mariane Cardoso
{"title":"上颌第一磨牙拔牙时口腔浸润阿替卡因与口腔和腭浸润利多卡因的自我报告疼痛：一项非劣效性随机临床试验。","authors":"Danielle Cristina Alves Rigo, Pablo Silveira Santos, Bárbara Suelen Moccelini, Aurélio de Oliveira Rocha, Julia Maldonado Garcia, Isabela Ramos, Carla Miranda Santana, Mariane Cardoso","doi":"10.1016/j.adaj.2025.07.014","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Effective pain control is essential in pediatric dental procedures to ensure cooperation and minimize psychological trauma. Although lidocaine is the reference standard, articaine has been proposed as a less invasive alternative due to its superior diffusion properties.</p><p><strong>Methods: </strong>A randomized, single-blind, noninferiority clinical trial was conducted with 76 children aged 6 through 9 years requiring extraction of maxillary primary molars. Participants were allocated into 2 groups: single buccal infiltration with 4% articaine and conventional buccal and palatal infiltration with 2% lidocaine. The primary outcome was self-reported pain using a visual analog scale (ie, a 10-cm horizontal line where 0 represented no pain and 10 represented the most pain imaginable). Noninferiority was assessed with a predefined margin of 1.5 cm. Negative binomial regression was used to explore predictors of pain.</p><p><strong>Results: </strong>Mean (SD) pain scores were significantly higher in the articaine group (4.18 [3.41] cm) than the lidocaine group (1.68 [2.71] cm; P < .001). The upper limit of the 95% CI (3.90 cm) exceeded the noninferiority margin, precluding confirmation of noninferiority (P = .919). Results of regression analysis showed that articaine was associated with 2.15 times higher pain scores (P = .008) and increased heart rate correlated with increased pain (P = .023).</p><p><strong>Conclusions: </strong>Our findings do not support the use of buccal infiltration with 4% articaine only as a noninferior technique to conventional lidocaine infiltration with palatal injection in pediatric maxillary molar extractions.</p><p><strong>Practical implications: </strong>Buccal infiltration with articaine only may not be sufficient to ensure adequate anesthesia for extraction of maxillary primary molars. This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT05443009.</p>","PeriodicalId":17197,"journal":{"name":"Journal of the American Dental Association","volume":" ","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Danielle Cristina Alves Rigo, Pablo Silveira Santos, Bárbara Suelen Moccelini, Aurélio de Oliveira Rocha, Julia Maldonado Garcia, Isabela Ramos, Carla Miranda Santana, Mariane Cardoso\",\"doi\":\"10.1016/j.adaj.2025.07.014\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Effective pain control is essential in pediatric dental procedures to ensure cooperation and minimize psychological trauma. Although lidocaine is the reference standard, articaine has been proposed as a less invasive alternative due to its superior diffusion properties.</p><p><strong>Methods: </strong>A randomized, single-blind, noninferiority clinical trial was conducted with 76 children aged 6 through 9 years requiring extraction of maxillary primary molars. Participants were allocated into 2 groups: single buccal infiltration with 4% articaine and conventional buccal and palatal infiltration with 2% lidocaine. The primary outcome was self-reported pain using a visual analog scale (ie, a 10-cm horizontal line where 0 represented no pain and 10 represented the most pain imaginable). Noninferiority was assessed with a predefined margin of 1.5 cm. Negative binomial regression was used to explore predictors of pain.</p><p><strong>Results: </strong>Mean (SD) pain scores were significantly higher in the articaine group (4.18 [3.41] cm) than the lidocaine group (1.68 [2.71] cm; P < .001). The upper limit of the 95% CI (3.90 cm) exceeded the noninferiority margin, precluding confirmation of noninferiority (P = .919). Results of regression analysis showed that articaine was associated with 2.15 times higher pain scores (P = .008) and increased heart rate correlated with increased pain (P = .023).</p><p><strong>Conclusions: </strong>Our findings do not support the use of buccal infiltration with 4% articaine only as a noninferior technique to conventional lidocaine infiltration with palatal injection in pediatric maxillary molar extractions.</p><p><strong>Practical implications: </strong>Buccal infiltration with articaine only may not be sufficient to ensure adequate anesthesia for extraction of maxillary primary molars. This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT05443009.</p>\",\"PeriodicalId\":17197,\"journal\":{\"name\":\"Journal of the American Dental Association\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-09-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the American Dental Association\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.adaj.2025.07.014\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DENTISTRY, ORAL SURGERY & MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the American Dental Association","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.adaj.2025.07.014","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DENTISTRY, ORAL SURGERY & MEDICINE","Score":null,"Total":0}
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.
Background: Effective pain control is essential in pediatric dental procedures to ensure cooperation and minimize psychological trauma. Although lidocaine is the reference standard, articaine has been proposed as a less invasive alternative due to its superior diffusion properties.
Methods: A randomized, single-blind, noninferiority clinical trial was conducted with 76 children aged 6 through 9 years requiring extraction of maxillary primary molars. Participants were allocated into 2 groups: single buccal infiltration with 4% articaine and conventional buccal and palatal infiltration with 2% lidocaine. The primary outcome was self-reported pain using a visual analog scale (ie, a 10-cm horizontal line where 0 represented no pain and 10 represented the most pain imaginable). Noninferiority was assessed with a predefined margin of 1.5 cm. Negative binomial regression was used to explore predictors of pain.
Results: Mean (SD) pain scores were significantly higher in the articaine group (4.18 [3.41] cm) than the lidocaine group (1.68 [2.71] cm; P < .001). The upper limit of the 95% CI (3.90 cm) exceeded the noninferiority margin, precluding confirmation of noninferiority (P = .919). Results of regression analysis showed that articaine was associated with 2.15 times higher pain scores (P = .008) and increased heart rate correlated with increased pain (P = .023).
Conclusions: Our findings do not support the use of buccal infiltration with 4% articaine only as a noninferior technique to conventional lidocaine infiltration with palatal injection in pediatric maxillary molar extractions.
Practical implications: Buccal infiltration with articaine only may not be sufficient to ensure adequate anesthesia for extraction of maxillary primary molars. This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT05443009.
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There is not a single source or solution to help dentists in their quest for lifelong learning, improving dental practice, and dental well-being. JADA+, along with The Journal of the American Dental Association, is striving to do just that, bringing together practical content covering dentistry topics and procedures to help dentists—both general dentists and specialists—provide better patient care and improve oral health and well-being. This is a work in progress; as we add more content, covering more topics of interest, it will continue to expand, becoming an ever-more essential source of oral health knowledge.
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