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Clinical Trials/CTRI/2025/04/083885
CTRI/2025/04/083885CompletedNot Applicable

Anesthetic Efficacy of Hyaluronidase as an Adjuvant to Lignocaine-Epinephrine in Maxillary Anterior Extractions: A Randomized Controlled Trial

DR ROSHANI R AUTADE1 site in 1 country140 target enrollmentStarted: April 19, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
140
Locations
1
Primary Endpoint
pain, local anesthetic effect, time of onset of anesthesia, complications

Study Overview

Brief Summary

Maxillary anterior tooth extractions are routinely performed procedures under local anesthesia and account for 13.9% of total extractions. The efficacy of local anesthesia is paramount to ensure patient comfort, reduce anxiety, and facilitate a smooth procedure. The infiltration technique is commonly used for anesthesia, with lignocaine (lidocaine) being the anesthetic agent of choice in combination with epinephrine to prolong the anesthetic effect and minimize bleeding. Hyaluronidase is an enzyme that hydrolyses the hyaluronic component of the intercellular ground substance, hence the viscosity of the tissues is reduced permitting a wider spread of the local anesthetic solution.

The porous bone in the anterior maxilla offers an ideal medium for the diffusion of local anesthesia from the buccal to the palatal side of the associated tooth. When used in conjunction with hyaluronidase, this formulation facilitates the adequate distribution of the anesthetic, thereby ensuring sufficient analgesia and obviating the necessity for a painful palatal infiltration.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • patients requiring prophylactic or remedial extraction of maxillary central and lateral incisors.

Exclusion Criteria

  • Patient with co morbidities
  • History of immunosuppressant use within last 6 months
  • Past or ongoing chemotherapy or radiotherapy
  • Patients with altered hemodynamic values.
  • Women who are pregnant, lactating or taking oral contraceptives.
  • Allergy or hypersensitivity to any of the products used in the study.
  • Any pre operative infection or edema.

Outcomes

Primary Outcomes

pain, local anesthetic effect, time of onset of anesthesia, complications

Time Frame: immediately after administration of local anesthetic, 30,60,90,120sec and so on.

Secondary Outcomes

  • Time of onset of anesthesia after administration of Local Anesthetic solution, Other complication(Localized / systemic)

Investigators

Sponsor
DR ROSHANI R AUTADE
Sponsor Class
Other [Individual- Dr Roshani R. Autade (Principal Investigator)]
Responsible Party
Principal Investigator
Principal Investigator

Dr. Roshani R. Autade

Government Dental College and Hospital, Jamnagar

Study Sites (1)

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