Role of Herpesviruses as a Causative Factor in Acute Apical Abscess
University of California, San Francisco
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.
Description
This proposal is to test the valacyclovir+antibiotic treatment regimen that was developed during our pre-operative pain pilot study. Valacacylovir is a widely used medicine that is used to treat active herpesvirus. According to the figure 2 model of herpesvirus in symptomatic endodontic pathosis \[1\] the interventions aim to address the viral component of disease progression resulting in less pre-operative pain, post operative pain, and in faster healing of the associated lesion. Phase two involves recruitment of participants who: 1) present with swelling associated with an acute apical absce…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
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 defin…
Interventions
- DrugValacyclovir 500 MG
Consistent with the pilot study VEII will use a random number generator to randomly assign a Manila packet containing amoxicillin 500mg + Valtrex (valacyclovir 500mg x three times daily for 7 days). Opaque medication packaging and using standardized verbal and written instructions helps ensure blindness of the VEII calibrated clinician, and patients of the therapeutic group they were assigned to.
- DrugPlacebo
Consistent with the pilot study VEII will use a random number generator to randomly assign a Manila packet containing amoxicillin 500mg + Placebo (empty capsule). Opaque medication packaging and using standardized verbal and written instructions helps ensure blindness of the VEII calibrated clinician, and patients of the therapeutic group they were assigned to.
Location
- UCSF DentalSan Francisco, California