Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865848
Status:
TERMINATED
Last Update Posted:
2024-05-09
First Post:
2020-05-14
Brief Title:
Comparison of Articaine Mandibular Infiltration to Lidocaine Inferior Alveolar Nerve Block in Pediatric Patients
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Comparison of Articaine Mandibular Infiltration to Lidocaine Inferior Alveolar Nerve Block in Pediatric Patients
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
research operation issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 P005
Detailed 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 1100000 Epinephrine and Articaine 4 Articaine Hydrochloride with 1100000 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 parentguardian 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 childs body weight and will not exceed the maximum recommended 44 mgkg for Lidocaine and 7 mgkg 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 childs 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 patients reactions during the dental treatment Generally effective LA results in less negative and more positive patients 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
Lidocaine 2 Lidocaine Hydrochloride with 1100000 Epinephrine and Articaine 4 Articaine Hydrochloride with 1100000 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 parentguardian 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 childs body weight and will not exceed the maximum recommended 44 mgkg for Lidocaine and 7 mgkg 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 childs 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 patients reactions during the dental treatment Generally effective LA results in less negative and more positive patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None