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

NCT05585112 | Completed Phase 1 DMC

• 1 other identifier: Tishreen U _Local anesthesia
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Molar Incisor Hypomineralisation

Keywords

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

Outcome Measures

Primary Outcomes (4)

• injection 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 procedure

• injection 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 procedure

• 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 procedure

• 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 treatment procedure

Study Arms (2)

A (Lidocaine 2%)

ACTIVE COMPARATOR

26 children will be injected with 1 ml of lidocaine 2% with epinephrine

Drug: Lidocaine 2%

B (Articaine 4%)

EXPERIMENTAL

26 children will be injected with 1 ml of Articaine 4% with epinephrine.

Drug: Articaine 4%

Interventions

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

Also known as: A

A (Lidocaine 2%)

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

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.
• 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 .

You may not qualify if:

• children who are uncooperative
• allergic anesthetics used in the study
• children who show inflammation in the injection site.

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University

Latakia, Syria

Location

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 18, 2022
• Study Start: October 17, 2022
• Primary Completion: December 5, 2022
• Study Completion: December 25, 2022
• Last Updated: May 3, 2023

Record last verified: 2022-10

Locations

SY (1)