Clinical trial

Role of Herpesviruses as a Causative Factor in Acute Apical Abscess

Name

Valacyclovir

Description

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.

Trial arms

Trial start

2023-05-01

Estimated PCD

2024-05-30

Trial end

2024-11-30

Status

Recruiting

Phase

Early phase I

Treatment

Valacyclovir 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.

Arms:

valacyclovir group

Placebo

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.

Arms:

Control group

Size

250

Primary endpoint

Measurement of pain levels following treatment intervention

3 years

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}

Updated at

2023-07-12

1 organization

1 product

1 drug

3 indications

Organization

University of California, San Francisco

Product

Indication

Indication

Indication

Drug