Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment

Part of paid clinical trials in New York, New York.

Sponsor
New York University
Study ID
NCT06655454
Phase
PHASE2
Status
Recruiting
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Conditions

  • Analgesic Use
  • Pain Assessment
  • Quality of Life (QOL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Supplemental Postoperative Bupivacaine — DRUG
    This is the intervention of interest. A supplemental injection of bupivacaine will be given postoperatively to patients who are assigned this intervention.
  • Placebo Injection — DRUG
    This intervention will appear to give patients an additional injection, but no additional drug will be given.

Study Details

The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.

Key Dates

Start date
Nov 1, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supplemental Postoperative Bupivacaine
    An additional injection, 1 carpule (1.8 mL) of 0.5% bupivacaine with 1:200,000 epinephrine, will be given to patients in this treatment arm, after their standard endodontic procedure is complete.
  • Placebo Comparator: Mock/Placebo Injection
    If assigned to this arm, the patient will be shown the removal of a needle cap for an anesthetic syringe. The tip will be bent and placed in the patient's mouth, but no tissue penetration will occur. No solution of anesthetic will be delivered.
  • No Intervention: No Additional Injection
    After standard endodontic procedure, no additional injection will be given.

Primary Outcome Measure

Quality of life (scored based on the OHIP-14 questionnaire) [ Time Frame: Day of operation and daily for four days immediately following endodontic treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York University College of DentistryNew YorkNew York10010
Lorel E Burns, DDS, MS
[email protected]
212-998-9332
Lorel E Burns, DDS (PRINCIPAL_INVESTIGATOR)

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By research site
New York University College of Dentistry· New York, NY

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