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NCT Number: NCT05585112

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

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

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Key information

Conditions

Molar Incisor Hypomineralisation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tishreen University

Latakia, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: A

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

Other names: B

Primary outcomes

  1. injection pain

    Time frame: during the injection of local anesthesia procedure

    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)..

  2. injection pain

    Time frame: Immediately after the injection of local anesthesia procedure

    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" )

  3. dental pain

    Time frame: during procedure

    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)..

  4. dental pain

    Time frame: Immediately after treatment procedure

    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" )

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2022
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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