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Not yet recruiting NCT06980363

Hyaluronidase Enzymes and Local Anesthesia

Phase I Interventional Local Infiltration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: traditional inferior alveolar nerve block by articaine, hyaluronidase plus articain buccal infilteration.
Who it may be relevant to
Registry conditions: Local Infiltration. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of Articaine Plus Hyaluronidase Enzymes Infiltration Versus Traditional Inferior Alveolar Nerve Block for the Extraction of Mandibular Molars

Overview

* 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

Interventions

  • Drug traditional inferior alveolar nerve block by articaine
    use articaine for inferior alveolar nerve block with buccal infiltration to anesthetized lower molar teeth
  • Drug hyaluronidase plus articain buccal infilteration
    use of articain plus hyaluronidase enzyme buccal infiltration to anesthetized lower molar teeth

Primary outcome measures

  • visual analogue scale (VAS)0_10 [Time frame: Periprocedural]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06980363 · 2222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗