Back to resultsLocal Anesthesia With Lidocaine or Articaine for Molars Affected by MIH
Primary Purpose
Molar Incisor Hypomineralisation
Status
Completed
Phase
Phase 1
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Lidocaine 2%
Articaine 4%
Sponsored by
About this trial
This is an interventional treatment trial for Molar Incisor Hypomineralisation focused on measuring the local anesthesia, Lidocaine 2%, Articaine 4%, children, MIH molars.
Eligibility Criteria
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.
Sites / Locations
- Tishreen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
: A (Lidocaine 2%)
B (Articaine 4%)
Arm Description
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
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
Outcomes
Primary Outcome Measures
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)..
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" )
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)..
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" )
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05200884
Brief Title
Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH
Official Title
A Comparison the Effectiveness of Anesthesia With Lidocaine 2% or Articaine 4% in Children With Molar Incisor Hypomineralisation (MIH)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2022 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
June 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tishreen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralisation
Keywords
the local anesthesia, Lidocaine 2%, Articaine 4%, children, MIH molars.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
A randomized, controlled, crossover, double-blind clinical study, Comparison of articaine 4% and lidocaine 2%
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
: A (Lidocaine 2%)
Arm Type
Active Comparator
Arm Description
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
Arm Title
B (Articaine 4%)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2%
Other Intervention Name(s)
A
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Articaine 4%
Other Intervention Name(s)
B
Intervention Description
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
Primary Outcome Measure Information:
Title
dental pain
Description
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)..
Time Frame
during the injection of local anesthesia
Title
dental pain
Description
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" )
Time Frame
Immediately after the injection of local anesthesia
Title
dental pain
Description
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)..
Time Frame
during treatment
Title
dental pain
Description
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" )
Time Frame
Immediately after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabih Raslan, Dr
Organizational Affiliation
Tishreen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mai Haidar, Dr
Organizational Affiliation
Tishreen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tishreen University
City
Latakia
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
up to date, there is no decision about IPD sharing.
Learn more about this trial
Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH
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