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NCT Number: NCT06980363

Hyaluronidase Enzymes and Local Anesthesia

* 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

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Key information

Conditions

Local Infiltration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traditional inferior alveolar nerve block by articaine

Drug

use articaine for inferior alveolar nerve block with buccal infiltration to anesthetized lower molar teeth

hyaluronidase plus articain buccal infilteration

Drug

use of articain plus hyaluronidase enzyme buccal infiltration to anesthetized lower molar teeth

Primary outcomes

  1. visual analogue scale (VAS)0_10

    Time frame: Periprocedural

    Ask the patient to scoring his pain during the extraction by visualanalogue scale0_10 as 0 no pain and 10 sever pain

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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