Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH

NCT05200884 | Completed Phase 1 DMC

• 1 other identifier: Tishreen U _pediatricDentistry
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Molar Incisor Hypomineralisation

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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)..

  during the injection of local anesthesia

• 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" )

  Immediately after the injection of local anesthesia

• 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)..

  during treatment

• 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" )

  Immediately after the treatment

Study Arms (2)

: A (Lidocaine 2%)

ACTIVE COMPARATOR

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%

B (Articaine 4%)

EXPERIMENTAL

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

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

Also known as: A

: A (Lidocaine 2%)

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

Also known as: B

B (Articaine 4%)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 .

You may not qualify if:

• Teeth with non-response pulpitis Inflammation at the injection site.
• Allergy to the substances used in anesthesia.
• Presence of general or developmental medical conditions.

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University

Latakia, Syria

Location

Related Publications (1)

• 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.

  PMID: 37526883 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

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

Study Officials

• Nabih Raslan, Dr

  Tishreen University

  STUDY CHAIR

• Mai Haidar, Dr

  Tishreen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 21, 2022
• Study Start: January 22, 2022
• Primary Completion: March 25, 2022
• Study Completion: June 10, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-01

Locations

SY (1)