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Hyaluronidase Enzymes and Local Anesthesia

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06980363
Enrollment
20
Registered
2025-05-20
Start date
2025-06-01
Completion date
2025-08-27
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Infiltration

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

Interventions

DRUGtraditional inferior alveolar nerve block by articaine

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

DRUGhyaluronidase plus articain buccal infilteration

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

Sponsors

Fayoum University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
visual analogue scale (VAS)0_10PeriproceduralAsk the patient to scoring his pain during the extraction by visualanalogue scale0\_10 as 0 no pain and 10 sever pain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026