drugset / Trial / NCT05793905

Buffered Anesthetic Solution in the Treatment of Mandibular Primary Molars

NCT05793905

Phase 4 Completed 40 enrolled Damascus University
RandomizedCrossoverTriple-blindTreatment

Summary

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.

Timeline

Start
2022-12-01
Primary completion
2023-03-01
Completion
2023-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 2 % Other
Subject sodium bicarbonate Diagnostic / imaging agent 1.8 % Other
Background Epinephrine Other / unclassified Other

Indications

No indication recorded.