Clinical trial

Evaluation of the Effect of Buffered Anesthetic Solution (Lidocaine 2%) in the Effectiveness of Inferior Alveolar Nerve Block Injection During the Treatment of Mandibular Primary Molars

Name
UDDS-Pedo-03-2023
Description
In a prospective, randomized clinical trial, triple-blind, split-mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, which was non- buffered 2% lidocaine with 1:80,000 epinephrine. The pain will be assessed during inferior alveolar nerve block injection (IANB) and the effectiveness of anesthesia using the subjective Wong-Baker visual analog scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter. The investigator has confirmed the onset of anesthesia after lip tongue-numbing by probing the gingiva until there is no pain. Endo-ice has been used to assess the onset of pulp anesthesia.
Trial arms
Trial start
2022-12-01
Estimated PCD
2023-03-01
Trial end
2023-04-03
Status
Completed
Phase
Early phase I
Treatment
Buffered lidocaine in inferior alveolar nerve block injection
Buffered Lidocaine 2% with epinephrine 1.80000 mixed with 1.8% sodium bicarbonate in IANB injection in the treatment of bilateral primary mandibular molars
Arms:
Buffered lidocaine
Other names:
Buffered lidocaine
lidocaine 2% in inferior alveolar nerve block injection
Lidocaine 2% with epinephrine 1.80000 in IANB injection in the treatment of bilateral primary mandibular molars
Arms:
Lidocaine 2%
Size
40
Primary endpoint
Probing the gingiva
directly after asking the child about lip, tongue numbing every 30 seconds until there is no pain.
Endo - ice test
Every 30 seconds after confirmed soft tissues anaesthesia until the absence of pain.
Pulse rate
A minute before anaesthesia.
Pulse rate
20 seconds after the first quarter of the local anaesthesia.
Wong baker faces scale.
One minute after IANB injection
Sound, eye, motor scale (SEM)
Within five seconds from the start of the local anesthetic injection to completion
Eligibility criteria
Inclusion Criteria: * Children who are healthy and free of any underlying conditions that might make local anesthesia impossible to administer. * Children that are not allergic to (lidocaine, adrenaline, or sodium bicarbonate). * Children aged 6-10 years old * Cooperative children on Frankel scale (positive or absolute positive). * children needing bilateral (right and left) endodontic treatment for the mandibular primary molars. * A positive outcome on the cold test for the target tooth. Exclusion Criteria: * Uncooperative children on Frankel's scale (passive or absolute positive). * The presence of a fistula. * The presence of an abscess associated with the target tooth. * The presence of a periapical lesion radially. * Negative response to the cold test. * Children suffering from systemic conditions. * Children who are allergic to (lidocaine, adrenaline, sodium bicarbonate).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This clinical research aims to evaluate the effectiveness of buffered lidocaine in the treatment of bilateral primary molars', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Triple Masking: Patients, Investigators and Statistician', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-09-29

1 organization

2 products

1 indication

Product
Lidocaine