drugset / Trial / NCT06980363

Hyaluronidase Enzymes and Local Anesthesia

NCT06980363

Phase 1 Not yet recruiting 20 enrolled Fayoum University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

* For both groups, local anaesthesia will be administered by one single surgeon and the extraction will be performed by another single surgeon across all subjects. The surgeon performing the extraction will be blinded with regard to the local anaesthesia technique used in this study * A buccal infiltration injection of 1.5 ml of 4% articaine with 1:100,000 adrenaline (Septocaine, Septodont, New Castle, Del.) plus 1.5 ml of hyaluronidase enzyme (7.5IU/1ml) will be used in the study group while use 4% articaine with 1:100,000 adrenaline (Septocaine, Septodont, New Castle, Del.)only in traditional inferior alveolar nerve block in the control group * In study and control groups, VAS (visual analogue scale=is an unmarked, continuous, horizontal,100-mm line, anchored by the end points of "no pain" on the left and "worst pain" on the right ) will be used to evaluate the pain levels of the patients associated with the injection and during extraction

Timeline

Start
2025-06-01
Primary completion
2025-08-01
Completion
2025-08-27

Drugs

EvaluationDrugModalityDoseRoute
Subject rHuPH20 Protein / enzyme biologic 1.5 ml Other
Comparator Articaine Other / unclassified 1.5 ml Other

Indications

No indication recorded.