What is the mechanism of action of this treatment?

The most common treatments for Acute Apical Abscess include drainage, antibiotics, and sometimes surgical intervention. Cone Beam Computed Tomography (CBCT) is crucial for providing detailed 3D images, aiding in accurate diagnosis and treatment planning. Antibiotics, such as cobetalactamine, target the bacterial infection causing the abscess. This combination of precise imaging and effective antibiotic therapy ensures accurate diagnosis, targeted treatment, and monitoring of healing, which is vital for improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for Acute Apical Abscess include antibiotics, drainage, and root canal therapy. Antibiotics can cause side effects such as gastrointestinal upset, allergic reactions, and antibiotic resistance. Drainage procedures may lead to temporary pain, swelling, and infection at the incision site. Root canal therapy can result in postoperative pain, swelling, and, in rare cases, infection or damage to surrounding tissues. Cone Beam Computed Tomography (CBCT) used for detailed radiographic assessment is generally safe, but it exposes patients to a low dose of radiation, which is a consideration for repeated imaging.

What prior FDA approvals exist?

The FDA has approved various antibiotics for the treatment of acute apical abscesses, which are often used in conjunction with imaging techniques like Cone Beam Computed Tomography (CBCT) for detailed radiographic assessment. Commonly used antibiotics include penicillin, amoxicillin, and clindamycin, which target the bacterial infection causing the abscess. While specific FDA approvals for treatments directly involving CBCT are not detailed, CBCT is widely used in endodontics to provide high-resolution images that aid in the diagnosis and management of dental abscesses, ensuring precise treatment planning and monitoring of healing.

What other types of research exist?

Promising novel alternatives to Cone Beam Computed Tomography (CBCT) for detailed radiographic assessment of acute apical abscesses in 2024 include Magnetic Resonance Imaging (MRI) and advanced Ultrasonography. MRI offers excellent soft tissue contrast without ionizing radiation, making it a safer option for repeated imaging. Advanced Ultrasonography, with improved resolution and 3D imaging capabilities, provides a non-invasive and radiation-free alternative, although it may be less effective in visualizing bone structures compared to CBCT.

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Virus Therapy

Valacyclovir for Acute Apical Abscess Pain Management

Phase 2

Recruiting

Led By Mike Sabeti, DDS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must exhibit clinical evidence of pulp necrosis and acute apical abscess

Patient must be ≥ 18-year-old

Must not have

Patients currently taking antibiotics or antiviral medications

External or internal tooth resorption

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

All Individual Drugs Already Approved

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Valacyclovir may cause side effects like headache, nausea, stomach pain, vomiting; rarely more serious issues like kidney problems or blood disorders might occur. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I experience moderate to severe pain regularly.

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I am generally healthy with no or mild systemic disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on antibiotics or antiviral medications.

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I have tooth decay from inside or on the surface.

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I have gum disease around the edges of my teeth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of pain levels following treatment intervention

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: valacyclovir groupExperimental Treatment1 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 groupPlacebo Group1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Apical Abscess include drainage, antibiotics, and sometimes surgical intervention. Cone Beam Computed Tomography (CBCT) is crucial for providing detailed 3D images, aiding in accurate diagnosis and treatment planning. Antibiotics, such as cobetalactamine, target the bacterial infection causing the abscess. This combination of precise imaging and effective antibiotic therapy ensures accurate diagnosis, targeted treatment, and monitoring of healing, which is vital for improving patient outcomes.

[Use of a new cobetalactamine in the therapy of acute and chronic odontogenic processes].The flare-up phenomenon in endodontics: a clinical perspective and review.