Valacyclovir in Pain Management of Acute Apical Abscesses (NCT05266040) | Clinical Trial Compass
RecruitingPhase 2
Valacyclovir in Pain Management of Acute Apical Abscesses
United States60 participantsStarted 2023-10-25
Plain-language summary
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. Patients will be recruited from the same pool of participants as the Phase II clinical trial. Preoperative cone beam computed tomography (CBCT) scans will be taken as well as three and six month postoperative CBCT scans. The secondary outcomes form the Phase II randomized clinical trial will be clinical success and visible radiographic healing determined by CBCT images.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of pain levels following treatment intervention