MedTrace Logo

The Anesthetic and Analgesic Effect of Adjunct Liposomal Bupivacaine in Periodontal Surgical Procedures

NCT07725731 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-07-27

No results posted yet for this study

Summary

Participants are being asked to be a part of this study because they have been scheduled to receive a gum surgery to treat periodontal (gum) disease. After agreeing to participate a pain and medication log will be provided to participants and a 5 minute survey given.

Standard of care gum surgery will be done using local anesthesia with or without intravenous sedation according to the participant's preference. If the participant is sedated, they will be asked to have an escort to take them home after the surgery as is the standard of care.

At this visit, after the surgery is complete, the doctor will inject the area next to the area that surgery was done surgery with 4 ml (about a teaspoon) of one of two solutions decided by a random 1:1 draw. The participant will receive either liposomal bupivacaine (Exparel) which is a long-acting local anesthetic or 0.5% Bupivacaine HCl with a small amount of epinephrine, a medium-acting dental anesthetic.

After surgery, as standard of care, participants will be given instructions on taking over-the-counter medications as needed for pain.

Participants will be asked to fill out the pain survey and tablet log at specific times after leaving the clinic.

A standard of care follow-up visit with the doctor will be scheduled about 2 weeks after the surgery.

Conditions

  • Periodontal Surgery

Interventions

DRUG

0.5% Bupivacaine HCl

4 ml of bupivacaine 0.5% will be injected adjacent to the surgical site post-surgery

DRUG

Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

4 ml of Liposomal bupivacaine 13.3 mg/ml is injected adjacent to the surgical site post-surgery

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Angela Palaiologou-Gallis, DDS, MS · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2026-03-15
Completion
2026-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725731 on ClinicalTrials.gov