Valacyclovir for Acute Apical Abscess Pain Management

Overseen By Mike Sabeti, DDS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Must not be taking: Antibiotics, Antivirals

Disqualifiers: Smoking, Pregnancy, Periodontitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 week

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether valacyclovir, a medication typically used for viral infections, can alleviate pain and aid healing in individuals with acute apical abscesses, which are painful tooth infections. Researchers aim to determine if this drug can reduce pain before and after dental procedures and enhance healing compared to a placebo. Suitable participants experience persistent moderate to severe pain from a diagnosed acute apical abscess and have consented to standard dental treatments like pulpal debridement (removal of infected tissue) and drainage. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Will I have to stop taking my current medications?

The trial requires that you stop taking antibiotics or antiviral medications before participating.

Is there any evidence suggesting that valacyclovir is likely to be safe for humans?

Research shows that valacyclovir, a medication used to fight viruses, is generally safe. The FDA has approved it for treating other viral infections, like cold sores. Studies have examined its use for pain from dental abscesses, but results are mixed. Some studies suggest it might not effectively relieve pain after certain dental procedures.

Regarding safety, no specific reports of serious side effects have emerged when using valacyclovir for dental abscesses, indicating it is well-tolerated. However, like any medication, it can cause side effects, usually mild, such as headaches or nausea. Given its approval for other uses and the absence of severe side effects in studies, valacyclovir appears to be a safe option for many. Always consult a healthcare provider to ensure it's appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment options for acute apical abscess, such as antibiotics and pain relievers, valacyclovir is being explored for its antiviral properties. Researchers are excited about this treatment because it may target the viral component that some believe contributes to the pain and inflammation of dental abscesses. This approach could offer a new mechanism of action, potentially providing relief more quickly and effectively than traditional methods. Additionally, using valacyclovir could reduce the reliance on antibiotics, helping to combat antibiotic resistance.

What evidence suggests that valacyclovir might be an effective treatment for acute apical abscess?

Research has shown that valacyclovir might help manage pain in cases of acute apical abscesses, which are painful dental infections. Some studies suggest it could be useful for controlling pain in these situations. However, other research indicates that valacyclovir alone may not significantly reduce pain after emergency dental treatments for abscesses. The evidence is mixed, showing some potential but not guaranteed effectiveness. In this trial, participants will be divided into a valacyclovir group and a control group to better understand valacyclovir's effects in this area. ^{1 2 6 7 8}

Who Is on the Research Team?

Mike Sabeti, DDS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are in good health (ASA Class I or II) with a tooth abscess causing moderate to severe pain. They must have signs of apical disease on X-rays, agree to standard dental treatment after the study, and not be pregnant, nursing, smoking heavily, taking certain medications, or allergic to amoxicillin or valacyclovir.

Inclusion Criteria

I have a dead tooth nerve and a painful infection at the root.

I experience moderate to severe pain regularly.

I am generally healthy with no or mild systemic disease.

Exclusion Criteria

You've had bad reactions to amoxicillin or valacyclovir in the past.

My tooth has an unusual shape or was misdiagnosed today.

I am currently on antibiotics or antiviral medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either amoxicillin or amoxicillin + valacyclovir for 7 days to manage acute apical abscess pain

1 week

1 visit (in-person), daily follow-up calls

Follow-up

Participants are monitored for pain levels and analgesic use via telephone survey for 7 days post-treatment

1 week

Daily follow-up calls

Endodontic Treatment

Participants receive non-surgical root canal therapy at UCSF Dental Clinics

1 day

1 visit (in-person)

Long-term Follow-up

Participants return for recall examinations and CBCT scans at 3 and 6 months to assess clinical and radiographic healing

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Valacyclovir

Trial Overview

The study tests if Valacyclovir can manage pain better than a placebo in patients with acute apical abscesses. It's part of a larger research project looking at preoperative and postoperative pain and healing outcomes using CBCT scans before and months after treatment.

How Is the Trial Designed?

Group I: valacyclovir group Experimental Treatment 1 Intervention

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.

Group II: Control group Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

In a clinical trial involving 260 pediatric patients, hydrochloride valacyclovir demonstrated significantly higher efficacy in treating uncomplicated varicella compared to ribavirin, with an efficacy index of 0.86 versus 0.70 at the end of treatment.

The treatment with hydrochloride valacyclovir was found to be safe, with no severe adverse drug reactions reported, making it a reliable option for managing varicella in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Randomized controlled multi-center trial for treatment of varicella in pediatric patients with hydrochloride valacyclovir]. Yu, H., Zhu, QR., Wang, ZL., et al.[2018]

Valacyclovir is an effective antiviral treatment for genital herpes, showing similar efficacy to acyclovir and is the only drug approved for once-daily suppressive therapy, making it easier for patients to adhere to their treatment.

In treating herpes zoster, valacyclovir is more effective than acyclovir and equally effective as famciclovir in reducing pain duration and severity, while maintaining a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Valacyclovir for the treatment of genital herpes. Brantley, JS., Hicks, L., Sra, K., et al.[2018]

Citations

1.

signavitae.com

signavitae.com/articles/10.22514/sv.2025.081

Pain management in acute apical abscesses with ...

The findings suggest that valacyclovir monotherapy may not provide substantial pain relief following emergency chamber opening for acute apical abscesses.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34363831/

Valacyclovir in Pain Management of Acute Apical Abscesses

The present study points to valacyclovir as a promising adjunctive agent in pain control with acute apical abscesses.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0099239921004763

Valacyclovir in Pain Management of Acute Apical Abscesses

Conclusion. The present study points to valacyclovir as a promising adjunctive agent in pain control with acute apical abscesses.

4.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/apical-abscess

UCSF Apical Abscess Clinical Trials for 2025

UCSF is exploring Valacyclovir's role in managing these painful conditions through ongoing clinical trials. The research will help understand ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05266040?term=AREA%5BConditionSearch%5D(%22Periodontitis%22)%20AND%20AREA%5BInterventionSearch%5D(%22Antiviral%20Agents%22)&rank=3

Valacyclovir in Pain Management of Acute Apical Abscesses

The Virus in Endodontics (VE) phase I pilot study for preoperative pain will be analyzed and adjusted for the Phase II clinical trial.

6.

oss.signavitae.com

oss.signavitae.com/mre-signavitae/article/20250606-599/pdf/SV2024112701.pdf

Pain management in acute apical abscesses with ...

Conclusions: The findings suggest that valacyclovir monotherapy may not provide substantial pain relief following emergency chamber opening for ...

7.

withpower.com

withpower.com/trial/phase-2-periapical-abscess-4-2022-b83c7

Valacyclovir for Acute Apical Abscess Pain Management

This trial tests a treatment combining an antibiotic (amoxicillin) and an antiviral (valacyclovir) for patients with painful dental abscesses.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11075121/

Systemic antibiotics for symptomatic apical periodontitis and ...

This article is an update of "Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults" in volume 2018, CD010136.