Hyaluronidase Enzymes and Local Anesthesia

Fayoum University

Status and phase: Not yet enrolling; Phase 1

Conditions: Local Infiltration

Treatments: Drug: hyaluronidase plus articain buccal infilteration; Drug: traditional inferior alveolar nerve block by articaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06980363

2222

Details and patient eligibility

About

• 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medically stable patients
• Seeking for non surgical extraction of mandibular molar tooth

Exclusion criteria

• history of metabolic or systemic diseases affecting bone or healing process,

  • local infection
  • Grade III mobility
  • Neurological disorder
  • an analgesic use within 24 hours before anaesthesia administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

traditional inferior alveolar nerve block by articaine

Active Comparator group

Treatment:

Drug: traditional inferior alveolar nerve block by articaine

hyaluronidase plus articain buccal infiltration

Experimental group

Treatment:

Drug: hyaluronidase plus articain buccal infilteration