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 a treatment combining an antibiotic (amoxicillin) and an antiviral (valacyclovir) for patients with painful dental abscesses. It targets those who have swelling and cannot quickly get dental procedures. The treatment aims to reduce pain and help heal faster by addressing both bacterial and viral components of the infection. Amoxicillin is a commonly used antibiotic for dental abscesses, often prescribed to manage bacterial infections.

Will I have to stop taking my current medications?

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

Is valacyclovir generally safe for human use?

Valacyclovir is generally considered safe for human use, with clinical trials involving around 10,000 patients showing an acceptable safety profile for conditions like genital herpes and herpes zoster. However, in patients with kidney problems, dose adjustments are necessary to avoid serious side effects like neurotoxicity (nerve damage). ^{1 2 3 4 5}

How does the drug Valacyclovir differ from other treatments for acute apical abscess pain management?

Valacyclovir is unique because it is an antiviral medication typically used to treat infections caused by viruses, such as herpes. Its use for acute apical abscess pain management is novel, as this condition is usually treated with antibiotics and pain relievers, not antivirals. ^{6 7 8 9 10}

What data supports the effectiveness of the drug valacyclovir for managing pain in acute apical abscesses?

Valacyclovir is known to effectively reduce pain associated with herpes zoster (shingles) and genital herpes, which suggests it may help manage pain in conditions involving herpesviruses, like acute apical abscesses. ^{2 11 12 13 14}

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. United States pubmed.ncbi.nlm.nih.gov

Valacyclovir in Pain Management of Acute Apical Abscesses: A Randomized Placebo-Controlled Double-Blind Pilot Study. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Valacyclovir: a review of its antiviral activity, pharmacokinetic properties, and clinical efficacy. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Comparison between famciclovir and valacyclovir for acute pain in adult Japanese immunocompetent patients with herpes zoster. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Valaciclovir. A review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in herpesvirus infections. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Clinical utility of oral valacyclovir compared with oral acyclovir for the prevention of herpes simplex virus mucositis following autologous bone marrow transplantation or stem cell rescue therapy. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Valacyclovir-associated neurotoxicity in peritoneal dialysis patients. [2018]

7. China pubmed.ncbi.nlm.nih.gov

[Randomized controlled multi-center trial for treatment of varicella in pediatric patients with hydrochloride valacyclovir]. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Neurotoxicity of valacyclovir in peritoneal dialysis: a pharmacokinetic study. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Valacyclovir for the treatment of genital herpes. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of apical trephination on postoperative pain and swelling in symptomatic necrotic teeth. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Prevention of apical periodontal ligament pain: a preliminary report of 100 vital pulp cases. [2018]

12. Australia pubmed.ncbi.nlm.nih.gov

Effect of supraperiosteal injection of dexamethasone on postoperative pain. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Success of maintaining apical patency in teeth with periapical lesion: a randomized clinical study. [2021]

14. Germany pubmed.ncbi.nlm.nih.gov

[Pain management in chronic pancreatitis and chronic inflammatory bowel diseases]. [2021]