Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
Tishreen U _Local anesthesia
Description
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
Trial arms
Trial start
2022-10-17
Estimated PCD
2022-12-05
Trial end
2022-12-25
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
A (Lidocaine 2%)
Other names:
A
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
Arms:
B (Articaine 4%)
Other names:
B
Size
26
Primary endpoint
injection pain
during the injection of local anesthesia procedure
injection pain
Immediately after the injection of local anesthesia procedure
dental pain
during procedure
dental pain
Immediately after treatment procedure
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A randomized, controlled, crossover, Triple-blinding clinical study, Comparison of articaine 4% and lidocaine 2%', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'as neither the child/parent, the investigator who performed the anesthesia/treatment, nor the assessors were aware of the type of anesthetic solution in order to avoid bias towards one of the solutions', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}
Updated at
2023-05-03

1 organization

2 products

1 indication

Organization
Tishreen University
Product
Lidocaine
Indication
Molar Incisor Hypomineralisation
Product
Articaine