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

Molar Incisor Hypomineralisation Clinical Trial

Official title:

Comparative Study of Articaine 4% Versus Lidocaine 2% in Local Anesthesia and Permanent Maxillary First Molars Affected by MIH.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05585112
• Other study ID #: Tishreen U _Local anesthesia
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 17, 2022
• Est. completion date: December 25, 2022

Study information

• Verified date: October 2022
• Source: Tishreen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 25, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralisation

Intervention

Drug:
• Lidocaine 2%
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
• Articaine 4%
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

Locations

Country	Name	City	State
Syrian Arab Republic	Tishreen University	Latakia

Sponsors (1)

Lead Sponsor	Collaborator
Tishreen University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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