Articaine 4% Versus Lidocaine 2% for Local Anesthesia of MIH-affected Maxillary Molars

Comparative Study of Articaine 4% Versus Lidocaine 2% in Local Anesthesia and Permanent Maxillary First Molars Affected by MIH.

Comparison of injection pain with lidocaine and articaine. Comparison of the efficacy of lidocaine and articaine during treatment of MIH- maxillary molars.

Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children, aged 6-12years old

Study Overview

• Status: Completed
• Conditions: Molar Incisor Hypomineralisation
• Intervention / Treatment: Drug: Lidocaine 2%; Drug: Articaine 4%

Detailed Description

Background and Aims: Some dentists have difficulty obtaining effective anesthesia when treating MIH molars.

There are no studies comparing the effectiveness of lidocaine and articaine in MIH-maxillary molars.

Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children , aged 6-12 years old. Each child was randomly assigned to either articaine 4% or lidocaine 2% in their first session with the second solution being used at the second session.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Nabih Raslan, Dr; Phone Number: 00963999140762; Email: Raslan.nabih@tishreen.edu.sy
• Study Contact Backup: Name: Mai Haidar, Dr; Phone Number: 00963991209347; Email: mai.q.haidar@tishreen.edu.sy

Study Locations

• Syrian Arab Republic
  • Latakia, Syrian Arab Republic
    • Tishreen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Absolute positive or positive behavior according to the Frankel Scale.
• child is not under the effect of any analgesics or sedatives and their weight was more than 20 kg.
• Healthy, both physically and mentally
• A child with a MIH-affected maxillary permanent first molar on the right and left sides .

Exclusion Criteria:

• children who are uncooperative
• allergic anesthetics used in the study
• children who show inflammation in the injection site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A (Lidocaine 2%); 26 children will be injected with 1 ml of lidocaine 2% with epinephrine	Drug: Lidocaine 2%; The child will be injected with lidocaine 2%,after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and pain after injection and treatment will be evaluated using the Wong-Baker faces pain rating scale; Other Names: A
Experimental: B (Articaine 4%); 26 children will be injected with 1 ml of Articaine 4% with epinephrine.	Drug: Articaine 4%; The child will be injected with 4% Articaine, after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and Wong-Baker faces pain rating scale; Other Names: B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
injection pain	evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain)..	during the injection of local anesthesia procedure
injection pain	self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10,which represents "hurts like the worst pain imaginable" )	Immediately after the injection of local anesthesia procedure
dental pain	evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain)..	during procedure
dental pain	self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10,which represents "hurts like the worst pain imaginable" )	Immediately after treatment procedure

Collaborators and Investigators

• Sponsor: Tishreen University
• Investigators: Principal Investigator: Mai Haidar, Dr, Tishreen University

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): December 25, 2022

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: local anesthesia; Lidocaine 2%; Articaine 4%; molars
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypoplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Carticaine
• Other Study ID Numbers: Tishreen U _Local anesthesia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No