Hyaluronidase Enzymes and Local Anesthesia

NCT ID: NCT06980363

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-08-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

traditional inferior alveolar nerve block by articaine

Group Type: ACTIVE_COMPARATOR

traditional inferior alveolar nerve block by articaine

Intervention Type: DRUG

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

hyaluronidase plus articain buccal infiltration

Group Type: EXPERIMENTAL

hyaluronidase plus articain buccal infilteration

Intervention Type: DRUG

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

Interventions

traditional inferior alveolar nerve block by articaine

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

Intervention Type: DRUG

hyaluronidase plus articain buccal infilteration

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mohsen

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2222

Identifier Type: -

Identifier Source: org_study_id