NCT05200884 - Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH | Crick

Overview

Aims: Comparison of injection pain with lidocaine and articaine in children with MIH . Comparison of the efficacy of lidocaine and articaine during treatment of MIH molars. Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children, aged 6-12years old

Background and Aims: Effectively achieving anesthesia is one of the difficulties a dentist faces when treating MIH molar There are no studies comparing the effectiveness of lidocaine and articaine in MIH molar Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children , aged 6-12 years old Each child will receive either lidocaine or articaine at their ﬁrst or second visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

20

Conditions

Molar Incisor Hypomineralisation

Interventions

Lidocaine 2%DRUG

The child will be injected with lidocaine 2% and After 10 minutes 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 and After 10 minutes the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and face 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. * Healthy, both physically and mentally. * Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment. * A child with a MIH-affected mandibular permanent first molar on the right and left sides . Exclusion Criteria: * Teeth with non-response pulpitis Inflammation at the injection site. * Allergy to the substances used in anesthesia. * Presence of general or developmental medical conditions.

Locations (1)

Tishreen University

Latakia, Syria

Outcomes

Primary Outcomes

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 the injection of local anesthesia

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 the injection of local anesthesia

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 treatment

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 the treatment