Valacyclovir in Pain Management of Acute Apical Abscesses
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Acute Apical Abscess, Pain, Acute
In brief
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.
Key facts
- Study ID
- NCT05266040
- Run by
- University of California, San Francisco
- People needed
- 60
- Starts
- 2023-10-25
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-05-30
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify 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
- 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
You may not qualify 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)
- Patients currently taking antibiotics or antiviral medications
Where it is running
- UCSF Dental — San Francisco, California, United States (enrolling)
Full record on ClinicalTrials.gov
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