Periodontal SurgeryPhase 1/2NCT07725731
The Anesthetic and Analgesic Effect of Adjunct Liposomal Bupivacaine in Periodontal Surgical Procedures
A Phase 1/2 study testing 0.5% Bupivacaine HCl and Liposomal Bupivacaine (EXPAREL®)/Bupivacaine in people with Periodontal Surgery, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Periodontal Surgery
- What is being tested?
- 0.5% Bupivacaine HCl and Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to 2 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
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.
Read more
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.
Read the detailed description
A randomized, double blinded clinical trial investigating the analgesic and anesthetic effect of liposomal bupivacaine when used after periodontal surgical procedures in addition to standard of care provided local anesthesia. These parameters will be compared to a control group that will receive 0.5% bupivacaine after completion of the procedure during which standard of care local anesthesia will be used.
Primary Objective:
- Postoperative pain as measured with a Visual Acuity Scale (VAS) (NRS-21) Secondary Objectives:
- Time (hours/minutes) for numbness due to local anesthetic to wear off
- Number of tablets of ibuprofen and acetaminophen consumed
- Conditions
- Periodontal Surgery
- Being tested
- 0.5% Bupivacaine HCl, Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
- Keywords
- Local anesthetic, Pain survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% Bupivacaine HClDrug
4 ml of bupivacaine 0.5% will be injected adjacent to the surgical site post-surgery
Liposomal Bupivacaine (EXPAREL®)/BupivacaineDrug
4 ml of Liposomal bupivacaine 13.3 mg/ml is injected adjacent to the surgical site post-surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: 0.5% Bupivacaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 to 168 hours
Secondary outcomes (3)
Time for numbness to wear off
Amount of time in hours/minutes for numbness due to local anesthetic to wear off
Measured: 3 to 168 hours
Number of of anti-inflammatory tablets taken
Number of ibuprofen/Motrin tablets taken post surgery
Measured: Baseline to 7 days
Number of analgesic tablets taken
Number of acetaminophen tablets taken post surgery
Measured: Baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start2 Oct 2024
- Primary completion15 Mar 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal SurgeryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site randomized controlled, 2 arm trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio
- Investigators
- Angela Palaiologou-Gallis, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725731
- Sponsor's protocol ID
- STUDY00000764
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented, as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anesthetic and Analgesic Effect of Adjunct Liposomal Bupivacaine in Periodontal Surgical Procedures
- ClinicalTrials.gov ID
- NCT07725731
- Acronym / sponsor ID
- STUDY00000764
- Conditions
- Periodontal Surgery
- Keywords
- Local anesthetic, Pain survey
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized, double blinded clinical trial investigating the analgesic and anesthetic effect of liposomal bupivacaine when used after periodontal surgical procedures in addition to standard of care provided local anesthesia. These parameters will be compared to a control group that will receive 0.5% bupivacaine after completion of the procedure during which standard of care local anesthesia will be used.
Primary Objective:
- Postoperative pain as measured with a Visual Acuity Scale (VAS) (NRS-21) Secondary Objectives:
- Time (hours/minutes) for numbness due to local anesthetic to wear off
- Number of tablets of ibuprofen and acetaminophen consumed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Single site randomized controlled, 2 arm trial
| Arm | Type | Receives |
|---|---|---|
| Adjunctive long acting local anesthesia post surgery | Experimental | Drug: Liposomal Bupivacaine (EXPAREL®)/BupivacaineThe experimental group will receive a longer lasting formulation of bupivacaine (liposomal bupivacaine) as an adjunctive local infiltration |
| Adjunctive standard of care local anesthetic | Active comparator | Drug: 0.5% Bupivacaine HClThe 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5% Bupivacaine HCl4 ml of bupivacaine 0.5% will be injected adjacent to the surgical site post-surgery | Drug | Adjunctive standard of care local anesthetic |
| Liposomal Bupivacaine (EXPAREL®)/Bupivacaine4 ml of Liposomal bupivacaine 13.3 mg/ml is injected adjacent to the surgical site post-surgery | Drug | Adjunctive long acting local anesthesia post surgery |
Primary outcome
Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale
Time frame: 3 to 168 hours
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 secondary outcomes
Time for numbness to wear off
Time frame: 3 to 168 hours
Number of of anti-inflammatory tablets taken
Time frame: Baseline to 7 days
Number of analgesic tablets taken
Time frame: Baseline to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented, as appropriate.
Related trials for Periodontal Surgery
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Palaiologou-Gallis, DDS, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 0.5% Bupivacaine HCl and Liposomal Bupivacaine (EXPAREL®)/Bupivacaine in people with Periodontal Surgery, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale (time frame: 3 to 168 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.