Efficacy of EXPAREL in Comparison to Standard of Care for the Treatment of Post Operative Dental Implant Pain

Postsurgical pain following the Full Arch Surgical Therapy (FAST) dental implant surgery
procedure is commonly managed with a variety of interventions, including local infiltration
with short-acting local anesthetics during surgery and the use of postsurgical opioid and
non-opioid analgesics. Although this approach to managing postsurgical pain is considered
the current standard of care, its reliance on opioid analgesics to provide analgesia beyond
the duration of short-acting local anesthetics exposes patients to opioid-related adverse
events (ORAEs) that may delay their recovery and have other deleterious clinical
consequences. The primary objective of this study is to determine the efficacy and safety of
local infiltration of EXPAREL for the FAST dental implant surgery procedure compared to
standard of care.

Inclusion Criteria:

- Age 18 years or older;

- Ability to speak, read, and write in English;

- Ability to communicate via telephone;

- Scheduled to undergo FAST dental implant surgery procedure at a study center within
the next 30 days for both maxillary and mandibular repair with at least 4 upper and 4
lower teeth to be extracted;

- Willing to provide informed consent, participate in study, and comply with study
protocol.

Exclusion Criteria:

- Daily opioid consumption for more than 30 days prior to surgery;

- Any opioid consumption within 3 days prior to surgery.

- Prior treatment for alcohol, recreational drug, or opioid abuse.

- Hypersensitivity or allergy to local anesthetics, non steroidal anti-inflammatory
drugs, or opioids;

- Breastfeeding, pregnant, or contemplating pregnancy prior to surgery.