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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.

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05585112
Enrollment
26
Registered
2022-10-18
Start date
2022-10-17
Completion date
2022-12-25
Last updated
2023-05-03

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

Conditions

Molar Incisor Hypomineralisation

Keywords

local anesthesia, Lidocaine 2%, Articaine 4%, molars

Brief summary

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

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.

Interventions

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

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

Sponsors

Tishreen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

as neither the child/parent, the investigator who performed the anesthesia/treatment, nor the assessors were aware of the type of anesthetic solution in order to avoid bias towards one of the solutions

Intervention model description

A randomized, controlled, crossover, Triple-blinding 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
injection painduring the injection of local anesthesia procedureevaluated 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)..
dental painduring procedureevaluated 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 4, 2026