Valacyclovir in Pain Management of Acute Apical Abscesses

ConditionsAcute Apical Abscess Pain, Acute

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorUniversity of California, San Francisco

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Valacyclovir 500 MG
Drug
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.
Placebo
Drug
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: valacyclovir groupExperimental treatment 1 intervention

Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Measurement of pain levels following treatment intervention

Patients with an acute apical abscess circled the endodontic pain level from 0 to 10 .A predoctoral research assistant blinded to the study protocol phoned the study patients daily at a prearranged time to assess (1) pain level (Numerical Rating Scale \[NRS\]), and (2) analgesic use. NRS is a 1-dimensional scale that is quick and easily understood by patients. The NRS method assesses pain severity extremes, ranging from 0 to 10, and allows for both verbal (by telephone) and written administration. Different pain scales to quantify endodontic pain, such as the visual analog scale, are highly correlated with the NRS scale method.

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov

Apply now