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Valacyclovir in Pain Management of Acute Apical Abscesses

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ClinicalTrials.gov Identifier: NCT05266040
Recruitment Status : Not yet recruiting
First Posted : March 4, 2022
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Acute Apical Abscess Pain, Acute Drug: Valacyclovir 500 MG Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Herpesviruses as a Causative Factor in Acute Apical Abscess
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : November 30, 2024


Arm Intervention/treatment
Experimental: valacyclovir group
250 patients presenting with pain and a diagnosis of acute apical abscess will be recruited for the VEII preoperative pain and VEIII postoperative pain and clinical/radiographic healing phases of the clinical trial.
Drug: 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.

Placebo Comparator: Control group
250 patients presenting with pain and a diagnosis of acute apical abscess will be recruited for the VEII preoperative pain and VEIII postoperative pain and clinical/radiographic healing phases of the clinical trial.
Drug: 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.




Primary Outcome Measures :
  1. Measurement of pain levels following treatment intervention [ Time Frame: 3 years ]

    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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05266040


Contacts
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Contact: Mike Sabeti, DDS 415-476-0822 Mike.Sabeti@ucsf.edu

Locations
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United States, California
UCSF Dental
San Francisco, California, United States, 94143
Contact: mike sabeti, DDS    415-476-0822    mike.sabeti@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Mike Sabeti, DDS University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05266040    
Other Study ID Numbers: Valacyclovir
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Abscess
Periapical Abscess
Acute Pain
Suppuration
Infections
Inflammation
Pathologic Processes
Pain
Neurologic Manifestations
Periapical Periodontitis
Periapical Diseases
Jaw Diseases
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases
Periodontitis
Valacyclovir
Antiviral Agents
Anti-Infective Agents