Comparison of Articaine Mandibular Infiltration to Lidocaine Inferior Alveolar Nerve Block in Pediatric Patients

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT04865848

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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 (P<0.05).

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Procedure: Dental local anesthesia	N/A

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 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

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Comparison of Articaine Mandibular Infiltration to Lidocaine Inferior Alveolar Nerve Block in Pediatric Patients

Actual Study Start Date :

Jun 5, 2019

Anticipated Primary Completion Date :

Jun 5, 2021

Anticipated Study Completion Date :

Jun 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mandibular infiltration dental anesthesia with Articaine Step-by-step: Reflect tissue to expose injection site. Orient bevel of the needle to be parallel to the bone and insert needle into mucobuccal fold Proceed to the depth that approximates the apices of the buccal roots of the primary molars. Aspirate. Deposit bolus of local anesthetic slowly at a rate of 1 ml/min. Remove needle. A subsequent lingual infiltration is delivered. The armamentarium includes: 4% articaine HCl with 1:100,000 epinephrine (Septocaine ®, Septodont, Lancaster, Penn. USA) in 1.7 ml cartridges and 30-gauge short needle manufactured by Henry Schein® (Melville, N.Y., USA). All injections are given using a self-aspirating syringe (A-Titan, Orchard Park, N.Y., USA).	Procedure: Dental local anesthesia Dental local anesthesia
Active Comparator: Inferior Alveolar Nerve Block with Lidocaine Step-by-step: Dry injection site with gauze. The barrel of the syringe should be directed on a plane between the two primary molars on the opposite side of the arch. It is advisable to inject a small amount of the solution as soon as the tissue is penetrated and to continue to inject minute quantities as the needle is directed toward the mandibular foramen. Insert to the depth that is adjacent to bone. Aspirate. Slowly inject bolus of anesthetic at a rate of 1 ml/min. Remove needle. The armamentarium includes 2% lidocaine HCl with 1:100,000 epinephrine (Henry Schein ® Lidocaine, Novocol, Cambridge, Ontario, Canada) in 1.7 ml cartridges, as well as 27-gauge long needles manufactured by Henry Schein® (Melville, N.Y., USA). All injections are given using a self-aspirating syringe (A-Titan, Orchard Park, N.Y., USA).	Procedure: Dental local anesthesia Dental local anesthesia

Arm

Intervention/Treatment

Experimental: Mandibular infiltration dental anesthesia with Articaine

Step-by-step: Reflect tissue to expose injection site. Orient bevel of the needle to be parallel to the bone and insert needle into mucobuccal fold Proceed to the depth that approximates the apices of the buccal roots of the primary molars. Aspirate. Deposit bolus of local anesthetic slowly at a rate of 1 ml/min. Remove needle. A subsequent lingual infiltration is delivered. The armamentarium includes: 4% articaine HCl with 1:100,000 epinephrine (Septocaine ®, Septodont, Lancaster, Penn. USA) in 1.7 ml cartridges and 30-gauge short needle manufactured by Henry Schein® (Melville, N.Y., USA). All injections are given using a self-aspirating syringe (A-Titan, Orchard Park, N.Y., USA).

Procedure: Dental local anesthesia

Dental local anesthesia

Active Comparator: Inferior Alveolar Nerve Block with Lidocaine

Step-by-step: Dry injection site with gauze. The barrel of the syringe should be directed on a plane between the two primary molars on the opposite side of the arch. It is advisable to inject a small amount of the solution as soon as the tissue is penetrated and to continue to inject minute quantities as the needle is directed toward the mandibular foramen. Insert to the depth that is adjacent to bone. Aspirate. Slowly inject bolus of anesthetic at a rate of 1 ml/min. Remove needle. The armamentarium includes 2% lidocaine HCl with 1:100,000 epinephrine (Henry Schein ® Lidocaine, Novocol, Cambridge, Ontario, Canada) in 1.7 ml cartridges, as well as 27-gauge long needles manufactured by Henry Schein® (Melville, N.Y., USA). All injections are given using a self-aspirating syringe (A-Titan, Orchard Park, N.Y., USA).

Procedure: Dental local anesthesia

Dental local anesthesia

Outcome Measures

Primary Outcome Measures

Dental anesthesia was effective to permit the dental treatment to be completed without pain experience of the participant. [The outcomes (presence or absence of pain perception) are evaluated immediately after the dental treatment is completed as well as up to 24 hour later (as the parent is able to contact the principal investigator and report any issues).]
Completion of planned dental treatment; Supplemental anesthesia not required; Lack of adverse events.

Secondary Outcome Measures

The patient rated positively the pain experience during procedure. [Immidiatelly after procedure]
Patient completes the Wong Baker FACE rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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);

Exclusion Criteria:

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;