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

NCT07725731 | Completed Phase 1 FDA Drug

• 1 other identifier: STUDY00000764
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Local anesthetic; Pain survey

Outcome Measures

Primary Outcomes (1)

• Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale

  Pain perceived at regular time intervals using a Visual Analogue Scale (NRS-21) rating their pain at specific time points on a scale from 0 to 10 with 0.5 points in between. A higher score indicates more pain.

  3 to 168 hours

Secondary Outcomes (3)

• Time for numbness to wear off

  3 to 168 hours

• Number of of anti-inflammatory tablets taken

  Baseline to 7 days

• Number of analgesic tablets taken

  Baseline to 7 days

Study Arms (2)

Adjunctive long acting local anesthesia post surgery

EXPERIMENTAL

The experimental group will receive a longer lasting formulation of bupivacaine (liposomal bupivacaine) as an adjunctive local infiltration

Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

Adjunctive standard of care local anesthetic

ACTIVE COMPARATOR

The control group will receive a commonly used in dentistry local anesthetic (0.5% bupivacaine HCL) as an adjunctive analgesic after the end of the procedure.

Drug: 0.5% Bupivacaine HCl

Interventions

0.5% Bupivacaine HCl DRUG

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

Adjunctive standard of care local anesthetic

Liposomal Bupivacaine (EXPAREL®)/Bupivacaine DRUG

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

Adjunctive long acting local anesthesia post surgery

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability of subject to understand and the willingness to sign a written informed consent document.
• Males and females; Age 18 to 89 years old
• Require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures
• In either the maxillary or mandibular arch.

You may not qualify if:

• Pregnancy, or those planning to become pregnant
• Allergy or any medical issue using Bupivacaine
• Inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
• Non-English speaking
• Patients requiring narcotic medications for IV sedation
• Patients requiring either IV or oral steroids during the perioperative period
• Patients with liver disease

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Angela Palaiologou-Gallis, DDS, MS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Subjects will be randomized to one of the two groups with simple randomization. Prior to the beginning of the surgical procedure, the PI will request that a faculty member not involved in the case randomly select a sealed envelope with the intervention named inside and hand it to the PI. The PI will prepare the solution selected in a non-labeled syringe and hand it to the surgeon. The surgeon, patient and faculty staffing the case will be blinded as to the contents of the syringe
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Program Director, Graduate Periodontics

Model Details: Single site randomized controlled, 2 arm trial

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: October 2, 2024
• Primary Completion: March 15, 2026
• Study Completion: June 2, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion and data analysis and acceptance by a peer review journal

Locations

US (1)