Valacyclovir in Pain Management of Acute Apical Abscesses

NCT05266040 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Valacyclovir
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Measurement of pain levels following treatment intervention

  Patients with an acute apical abscess circled the endodontic pain level from 0 to 10 .A predoctoral research assistant blinded to the study protocol phoned the study patients daily at a prearranged time to assess (1) pain level (Numerical Rating Scale \[NRS\]), and (2) analgesic use. NRS is a 1-dimensional scale that is quick and easily understood by patients. The NRS method assesses pain severity extremes, ranging from 0 to 10, and allows for both verbal (by telephone) and written administration. Different pain scales to quantify endodontic pain, such as the visual analog scale, are highly correlated with the NRS scale method.

  3 years

Study Arms (2)

valacyclovir group

EXPERIMENTAL

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.

Drug: Valacyclovir 500 MG

Control group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Valacyclovir 500 MG DRUG

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.

valacyclovir group

Placebo DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Dental

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Acute Pain

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mike Sabeti, DDS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Sabeti, DDS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: March 4, 2022
• Study Start: October 25, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)