Valacyclovir in Pain Management of Acute Apical Abscesses
Primary Purpose
Acute Apical Abscess, Pain, Acute
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Valacyclovir 500 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Apical Abscess
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
Sites / Locations
- UCSF DentalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
valacyclovir group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05266040
First Posted
January 18, 2022
Last Updated
July 11, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT05266040
Brief Title
Valacyclovir in Pain Management of Acute Apical Abscesses
Official Title
Role of Herpesviruses as a Causative Factor in Acute Apical Abscess
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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 abscess originating from endodontic origin, 2) present with inadequate time or finances to proceed with either pulpal debridement or incision and drainage, 3) have undergone root canal therapy and present with a swelling associated with endodontic flare-up, or 4) have undergone pulpal therapy procedure, present with swelling associated with an endodontic flare-up, and require antibiotic treatment. Upon diagnosis of acute apical abscess, the patients will be invited to participate in the present study. Two groups will be divided randomly and patients will be given informed consent, verbally and written. Patients in the control group will receive a prescription for amoxicillin 500 milligrams (mg) (three times daily for 7 days), while patients in the intervention group will receive a prescription for amoxicillin 500mg + Valtrex (valacyclovir 500mg x three times daily for 7 days). During the 7 day follow-up period, patients will be actively monitored via telephone survey. The questionnaire will be performed by a dental assistant without knowledge of the clinical status of the patient. The questionnaire will be based on an 11-point numerical rating scale (NRS 0-10 scale). Patients will furthermore be asked to report the amount , if any, of analgesics used to manage symptoms.
Following the 7 day follow-up period patients will receive free endodontic treatment at University of California at San Francisco (UCSF) Postgraduate Endodontics Clinic. Non-surgical root canal therapy will be performed at the UCSF Dental Clinics by endodontic providers. Pre-operative CBCT scans will be taken. Customary therapy (root canal therapy) will be performed to treat the condition after the full course of antibiotics/antivirals have been completed (approximately 7 days following initial visit). Root canal therapy consists of removal of dental caries and infected pulp tissue, including debridement and disinfection of the internal root surfaces prior to filling. If the participant in the study experiences wishes to discontinue the study and seek emergency root canal treatment, pulpal debridement and/or incision and drainage will be performed as soon as possible. Intra-operative pain measurements using the visual analog scale (VAS) will be assessed. Participants will be followed up with a questionnaire for 7 days following root canal therapy. Participants will be asked the same questionnaire from the VE Preoperative phase which discovers the amount of analgesics needed for pain. Participants will return for recall examinations at 3 and 6 months. CBCT scans will be taken at the 3 and 6 month recall intervals.
Randomization : Consistent with the pilot study, phase II will use a random number generator to randomly assign a Manila packet containing either amoxicillin 500mg (three times daily for 7 days), or for 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 phase II calibrated clinician, and patients of the therapeutic group they were assigned to.
Recruitment and Retention: 250 patients presenting with pain and a diagnosis of acute apical abscess will be recruited for the phase II preoperative pain and postoperative pain and clinical/radiographic healing phases of the clinical trial. The patients will represent the diversity of the San Francisco, California (CA) population. The anticipated retention rate is 90% for the phase II clinical trial, consistent with pilot study. Patients are likely to return for free endodontic treatment and thus analysis on the day of treatment will likely have a high retention rate. A decrease in retention likely at the 3 and 6 month recall visits due to the resolution of pain and thus lack of motivation to participate. Approved retention incentives such as free parking and transportation may assist in participant retention
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Apical Abscess, Pain, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
valacyclovir group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Valacyclovir 500 MG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Measurement of pain levels following treatment intervention
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Sabeti, DDS
Phone
415-476-0822
Email
Mike.Sabeti@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Sabeti, DDS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Dental
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mike sabeti, DDS
Phone
415-476-0822
Email
mike.sabeti@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Valacyclovir in Pain Management of Acute Apical Abscesses
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