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

Phase 1

Completed

• Conditions: Molar Incisor Hypomineralisation
• Interventions: Drug: Lidocaine 2%; Drug: Articaine 4%

• Registration Number: NCT05585112
• Lead Sponsor: Tishreen University

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

Detailed Description

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-15
• Study Start: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-18
• Primary Completion: 2022-12-05
• Study Completion: 2022-12-25
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A (Lidocaine 2%)	Lidocaine 2%	26 children will be injected with 1 ml of lidocaine 2% with epinephrine
B (Articaine 4%)	Articaine 4%	26 children will be injected with 1 ml of Articaine 4% with epinephrine.

Primary Outcome Measures

Name	Time	Method
injection pain	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" )
dental pain	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" )

Trial Locations

Locations (1)

Tishreen University; 🇸🇾 Latakia, Syrian Arab Republic