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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new way to manage pain during and after root canals.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measurement of pain levels following treatment intervention

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
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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,305 Total Patients Enrolled
Mike Sabeti, DDSPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Valacyclovir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05266040 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which demographic is this research endeavor open?

"This clinical trial is open to 250 individuals aged 18-80 exhibiting signs of acute pain. Additionally, they must be in good overall health (ASA Class I or II), have evidence of pulp necrosis and apical abscesses that can be seen on an imaging scan such as periapical radiography or cone beam computed tomography, consent to undergo conventional pulpal debridement at the end of the study, and report moderate to severe levels of pain (4-10)."

Answered by AI

Is this research endeavor restricted to persons over 35 years of age?

"The terms of participation in this clinical trial requires that the patient be aged between 18 and 80 years. There are 22 studies targeting people younger than 18, while 130 trials involve patients above 65 years old."

Answered by AI

Is the research study still accepting participants?

"The clinicaltrial.gov data suggests that this medical study is no longer recruiting patients, since the last update was posted on March 2nd 2022. Nonetheless, 163 other trials are still actively looking for participants at present."

Answered by AI

Has the FDA sanctioned Valacyclovir 500 MG for public use?

"There is limited clinical data backing the safety of Valacyclovir 500 MG, so it achieved a score of 2."

Answered by AI
~21 spots leftby May 2024