Recruiting PHASE2 Acute Apical Abscess

New treatment option for Acute Apical Abscess

Official title Valacyclovir in Pain Management of Acute Apical Abscesses

ClinicalTrials.gov ID: NCT05266040

What this study is testing

What is Valacyclovir 500 MG?

Valacyclovir 500 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for acute apical abscess.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80. Healthy volunteers may be eligible.

You may be able to join 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

You likely can't join 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)
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • San Francisco, California, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.