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Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH

A Comparison the Effectiveness of Anesthesia With Lidocaine 2% or Articaine 4% in Children With Molar Incisor Hypomineralisation (MIH)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05200884
Enrollment
20
Registered
2022-01-21
Start date
2022-01-22
Completion date
2022-06-10
Last updated
2022-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar Incisor Hypomineralisation

Keywords

the local anesthesia, Lidocaine 2%, Articaine 4%, children, MIH molars.

Brief summary

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

Detailed description

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.

Interventions

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

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

Sponsors

Tishreen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.

Intervention model description

A randomized, controlled, crossover, double-blind clinical study, Comparison of articaine 4% and lidocaine 2%

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
dental painduring the injection of local anesthesiaevaluated 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)..

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026