Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial Description

This is a parallel design randomized controlled trial that aims to evaluate the effectiveness of mandibular infiltration anesthesia with Articaine in comparison to IANB with Lidocaine used for restorative and pulp therapy procedures in pediatric patients. Lidocaine (2% Lidocaine Hydrochloride with 1:100,000 Epinephrine) and Articaine (4% Articaine Hydrochloride with 1:100,000 Epinephrine) are compared and evaluated for their effectiveness of anesthetizing primary mandibular molars for restorative and pulp therapy procedures. A number of clinical and behavioral variables including blood pressure, pulse, physical movements, and pain perception are evaluated. Participants for this study will be recruited from the pool of patients attending the Post-graduate (PG) clinic at the Pediatric Dentistry Department of the College of Dentistry (COD), University of Illinois at Chicago (UIC). Inclusion and exclusion criteria are specified separately for the selected patients and for the teeth involved. Informed consent from the parent/guardian and assent from the pediatric participant (7 years of age and older) will be obtained and signed. This is a prospective randomized clinical trial utilizing a random digit table for participant allocation into either the Articaine Group or the Lidocaine Group. The dosage of LA will be determined by the child's body weight and will not exceed the maximum recommended 4.4 mg/kg for Lidocaine and 7 mg/kg for Articaine. Before the injection, 20% Benzocaine topical anesthetic gel will be applied at the injection site with a cotton swab for approximately 3 minutes over dry mucosa. The randomly assigned LA, either Lidocaine IANB or Articaine infiltration, will be administered. One designated operator, an experienced specialist pediatric dentist, will conduct all LA injections to all participants. A trained and calibrated dental assistant (examiner A) will record the child's reactions during the LA administration using the Modified Behavioral Pain Scale (MBPS), adapted by Taddio et al. 1994. This scale allows for objective evaluation of pain using multiple criteria such as facial display, movement of extremities, movement of torso, and crying. A second trained and calibrated investigator (examiner B), a resident in pediatric dentistry, who is blinded to the type of LA agent used, will complete the planned dental treatment for the primary mandibular molars. Examiner B will complete MBPS (#B) evaluating the patient's reactions during the dental treatment. Generally, effective LA results in less negative and more positive patient's reactions to the dental care. In total, 15 examiners A and 17 examiners B will take part in the study. All examiners will be trained and calibrated with respect to the use of MBPS. During the entire treatment visit, each participant will wear a pulse and blood pressure monitor. The machine will produce automatic recordings every 10 minutes. Patients that experience distress and pain can exhibit increased pulse and blood pressure values outside of the considered normal range per age. At the end of the dental visit, the pediatric patient will be asked to complete a Wong-Baker FACES® Pain Response Scale (PRS) for feedback of their experience with the entire dental visit. The PRS contains six images of varying facial expression ranging from laughter to tears which are assigned at numerical value for objective evaluation. All used data will be coded and captured on specifically designed for the purposes of the study evaluation forms. The data gathered through all study forms will be transferred into Microsoft® Excel 2018 and the statistical analysis will be carried out with IBM SPSS Statistics. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04865848
Study type Interventional
Source University of Illinois at Chicago
Contact
Status Terminated
Phase N/A
Start date June 5, 2019
Completion date May 5, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas