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Completed

NCT Number: NCT05200884

Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH

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

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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: 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.

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.
  • 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.

Treatment and study plan

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

Other names: A

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

Other names: B

Primary outcomes

  1. dental pain

    Time frame: during the injection of local anesthesia

    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. dental pain

    Time frame: Immediately after the injection of local anesthesia

    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 treatment

    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 the treatment

    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

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 21, 2022
Registry last updated
Jul 15, 2022

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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