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CompletedNCT05200884Updated Jul 15, 2022

Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH

A Phase 1/2 interventional study of Lidocaine 2% and Articaine 4% in Molar Incisor Hypomineralisation, sponsored by Latakia University. Completed at 1 site in Syria. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-15.

Sponsored by Latakia University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Molar Incisor Hypomineralisation

Keywords

  • the local anesthesia
  • Lidocaine 2%
  • Articaine 4%
  • children
  • MIH molars.
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In context

Molar Hypomineralization

127 studies on the registry are indexed under Molar Hypomineralization; 43 are open to participants now.

This study's enrollment of 20 is below the median of 52 across 99 interventional studies indexed under Molar Hypomineralization.

Browse Molar Hypomineralization studies →

Lead sponsor

Latakia University is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    : A (Lidocaine 2%)

    20 children will be injected with 1 ml of lidocaine 2% with epinephrine. each one received lidocaine2% at his\\her first or second visit. Half of the total number of injections for 20 children i.e. 20 injections will be distributed randomly to the two drugs using the randomization table

    Drug: Lidocaine 2%

  • Experimental
    B (Articaine 4%)

    20 children will be injected with 1 ml of Articaine 4% with epinephrine. each one received articaine 4% at his\\her first or second visit. Half of the total number of injections for 20 children i.e.20 injections will be distributed randomly to the two drugs using the randomization table

    Drug: Articaine 4%

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

    Also known as: A

  • 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

    Also known as: B

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What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 site
  • Tishreen University
    Latakia, Syria
08

References and documents

Publications

  • Haidar M, Raslan N. Comparative study of articaine 4% versus lidocaine 2% in the local anesthesia of permanent mandibular first molars affected by MIH: a randomized controlled trial. Eur Arch Paediatr Dent. 2023 Oct;24(5):621-630. doi: 10.1007/s40368-023-00827-w. Epub 2023 Aug 1. PubMed 37526883 ↗

Individual participant data

Plan to share: Undecided — up to date, there is no decision about IPD sharing.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05200884
Lead sponsor
Latakia University
Responsible party
Sponsor
First posted
Jan 21, 2022
Start date
Jan 22, 2022
Primary completion
Mar 25, 2022
Completion
Jun 10, 2022
Last update
Jul 15, 2022

Study contacts

Nabih Raslan, Dr
study chair · Latakia University
Mai Haidar, Dr
principal investigator · Latakia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Carticaine

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