Recruiting
Phase 2

Valacyclovir

Sponsor:

UCLA

Code:

NCT05266040

Conditions

Acute Apical Abscess

Pain, Acute

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Valacyclovir 500 MG

Placebo

Study Details

Brief summary:

The Virus in Endodontics (VE) phase I pilot study for preoperative pain will be analyzed and adjusted for the Phase II clinical trial. The Phase II clinical trial on preoperative pain, postoperative pain, and clinical healing will involve 250 patients. Patients will be recruited from the same pool of participants as the Phase II clinical trial. Preoperative cone beam computed tomography (CBCT) scans will be taken as well as three and six month postoperative CBCT scans. The secondary outcomes form the Phase II randomized clinical trial will be clinical success and visible radiographic healing determined by CBCT images.

Conditions

Acute Apical Abscess

Pain, Acute

Study ID

NCT05266040

Start date

Oct 25, 2023

Status verified date

May, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patient must be ≥ 18-year-old
  • Patient must be systemically healthy; American Society of Anesthesiologists (ASA) Class I or II
  • Patient must exhibit clinical evidence of pulp necrosis and acute apical abscess
  • Patient must present with radiographic
  • signs of apical disease either by
  • periapical radiography or cone-beam
  • computed tomography
  • Patient consented to receive conventional pulpal debridement, incision and drainage at the end of the study
  • Persistent pain of moderate or higher level (>4) was the main inclusion criterion. Pain assessed as follows: 0 defined as no pain, 1-3 as mild pain, 4-6 as moderate pain, and 7-10 as severe pain

Exclusion Criteria:

  • Smokers (more than 10 cigarettes per day)
  • External or internal tooth resorption
  • Marginal periodontitis
  • Pregnant or nursing mothers (hormonal factors may influence the periapical condition)
  • Documented allergic or adverse reactions to amoxicillin or valacyclovir
  • Teeth with unusual anatomy or inaccurate clinical diagnosis on the day of treatment (i.e., partially necrotic pulp)
  • Patients currently taking antibiotics or antiviral medications

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: valacyclovir group

250 patients presenting with pain and a diagnosis of acute apical abscess will be recruited for the VEII preoperative pain and VEIII postoperative pain and clinical/radiographic healing phases of the clinical trial.

placebo comparator: Control group

250 patients presenting with pain and a diagnosis of acute apical abscess will be recruited for the VEII preoperative pain and VEIII postoperative pain and clinical/radiographic healing phases of the clinical trial.

Interventions

Valacyclovir 500 MG

Consistent with the pilot study VEII will use a random number generator to randomly assign a Manila packet containing amoxicillin 500mg + Valtrex (valacyclovir 500mg x three times daily for 7 days). Opaque medication packaging and using standardized verbal and written instructions helps ensure blindness of the VEII calibrated clinician, and patients of the therapeutic group they were assigned to.

Placebo

Consistent with the pilot study VEII will use a random number generator to randomly assign a Manila packet containing amoxicillin 500mg + Placebo (empty capsule). Opaque medication packaging and using standardized verbal and written instructions helps ensure blindness of the VEII calibrated clinician, and patients of the therapeutic group they were assigned to.

Primary outcome measure

  • Measurement of pain levels following treatment intervention [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Mike Sabeti, DDS

415-476-0822Mike.Sabeti@ucsf.edu

Locations

UCSF Dental

Recruiting

San Francisco, California, United States, 94143

Contacts

mike sabeti, DDS

415-476-0822mike.sabeti@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

May 30, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-05-30.