NCT05266040 Valacyclovir in Pain Management of Acute Apical Abscesses
| NCT ID | NCT05266040 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Francisco |
| Condition | Acute Apical Abscess |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-10-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Mike Sabeti, DDS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05266040 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Apical Abscess. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05266040 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05266040 currently recruiting?
Yes, NCT05266040 is actively recruiting participants. Contact the research team at Mike.Sabeti@ucsf.edu for enrollment information.
Where is the NCT05266040 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05266040 clinical trial?
NCT05266040 is sponsored by University of California, San Francisco. The principal investigator is Mike Sabeti, DDS at University of California, San Francisco. The trial plans to enroll 60 participants.