Hyaluronidase Enzymes and Local Anesthesia

NCT06980363 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 2222
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Local Infiltration

Outcome Measures

Primary Outcomes (1)

• visual analogue scale (VAS)0_10

  Ask the patient to scoring his pain during the extraction by visualanalogue scale0\_10 as 0 no pain and 10 sever pain

  Periprocedural

Study Arms (2)

traditional inferior alveolar nerve block by articaine

ACTIVE COMPARATOR

Drug: traditional inferior alveolar nerve block by articaine

hyaluronidase plus articain buccal infiltration

EXPERIMENTAL

Drug: hyaluronidase plus articain buccal infilteration

Interventions

traditional inferior alveolar nerve block by articaine DRUG

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

traditional inferior alveolar nerve block by articaine

hyaluronidase plus articain buccal infilteration DRUG

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

hyaluronidase plus articain buccal infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Interventions

Hyaluronoglucosaminidase

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 27, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05