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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05200884
Other study ID # Tishreen U _pediatricDentistry
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 22, 2022
Est. completion date June 10, 2022

Study information

Verified date January 2022
Source Tishreen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 10, 2022
Est. primary completion date March 25, 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. - 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


Intervention

Drug:
Lidocaine 2%
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
Articaine 4%
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

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 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 the injection of local anesthesia
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 the injection of local anesthesia
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 treatment
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 the treatment
See also
  Status Clinical Trial Phase
Completed NCT05585112 - Articaine 4% Versus Lidocaine 2% for Local Anesthesia of MIH-affected Maxillary Molars Phase 1/Phase 2
Recruiting NCT05812690 - Molar Incisor Hypomineralisation and Dental Anomalies
Completed NCT02084433 - Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia N/A