Comparison of Articaine Mandibular Infiltration to Lidocaine Inferior Alveolar Nerve Block in Pediatric Patients
Stopped early · Not applicable
Conditions studied: Anesthesia
In brief
This is a prospective, single-blind, parallel-design randomized controlled clinical trial that aims compare the effectiveness of articaine local infiltration to lidocaine inferior alveolar nerve block (IANB) for restorative treatment of primary mandibular molars (PMM). Four to 10-year-old children who needed PMM restorations are enrolled according to inclusion criteria and randomly allocated into the articaine or lidocaine group. One operator administers all local anesthesia (LA). Using the Modified Behavioral Pain Scale, 15 trained and calibrated examiners, blinded to LA type, evaluate the subjects' reactions during LA administration and treatment. Children rate their experience using the Wong-Baker FACES Pain Rating Scale. Subjects' blood pressure and pulse throughout the visit are recorded. Results are statistically analyzed using independent t-tests, Mann Whitney-U, and Repeated Measures ANOVA (P\<0.05).
Key facts
- Study ID
- NCT04865848
- Run by
- University of Illinois at Chicago
- People needed
- 42
- Starts
- 2019-06-05
- Expected to finish
- 2022-05-05
- Last updated by the study team
- 2024-05-09
Who can join
Age: 4 and older, up to 10. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Per patient:
- Medical status: ASA I: a normal, healthy patient;
- Age range: from 4 to 10 year old patients (males and females);
- Past history of dental treatment using local anesthetic;
- Cooperative for dental treatment (Frankel 3 or 4);
- Obtained informed consent to participate in the study;
- English speakers;
- B. Per tooth:
- Primary mandibular molar; Tooth that requires restorative dental care, including intracoronal or extracoronal restorations, due to:
- Caries;
- Pulp treatment (indirect pulp therapy, pulpotomy, or pulpectomy);
- Developmental defects;
- Tooth surface loss (erosion/attrition);
You may not qualify if…
- A. Per patient:
- Medical status: patients in category II,III, IV, V, VI of the ASA physical status classification system:
- Age: younger than 4 years of age or older than 10 years of age;
- No history of dental treatment using local anesthetic;
- Uncooperative for dental treatment (Frankel 1 or 2);
- Informed consent to participate in the study not obtained;
- Non-English speakers;
- B. Per tooth:
- Tooth other than mandibular primary molar
- Tooth requiring extraction
Where it is running
- College of Dentistry, Univesity of Illinois at Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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