NCT05585112 - Articaine 4% Versus Lidocaine 2% for Local Anesthesia of MIH-affected Maxillary Molars | Crick

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

26

Conditions

Molar Incisor Hypomineralisation

Interventions

Lidocaine 2%DRUG

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

Articaine 4%DRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Tishreen University

Latakia, Syria

Outcomes

Primary Outcomes

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)..

Time frame: 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" )

Time frame: 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)..

Time frame: 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" )

Time frame: Immediately after treatment procedure