Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH

Phase 1

Completed

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

• Registration Number: NCT05200884
• Lead Sponsor: Tishreen University

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

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.

Study Timeline

• Study First Submitted: 2021-12-15
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-21
• Study Start: 2022-01-22
• Primary Completion: 2022-03-25
• Study Completion: 2022-06-10
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B (Articaine 4%)	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
: A (Lidocaine 2%)	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

Primary Outcome Measures

Name	Time	Method
dental pain	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" )

Trial Locations

Locations (1)

Tishreen University; 🇸🇾 Latakia, Syrian Arab Republic