Acute Apical AbscessPhase 2NCT05266040
Valacyclovir in Pain Management of Acute Apical Abscesses
A Phase 2 study testing Valacyclovir 500 MG in people with Acute Apical Abscess and Pain, Acute, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Apical Abscess, Pain, Acute
- What is being tested?
- Valacyclovir 500 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSF Dental
San Francisco, California, 94143
mike sabeti, DDS, 415-476-0822, mike.sabeti@ucsf.edu
About this study
Official title: Role of Herpesviruses as a Causative Factor in Acute Apical Abscess
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.
Read the 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
- Conditions
- Acute Apical Abscess, Pain, Acute
- Being tested
- Valacyclovir 500 MG, Placebo
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir 500 MGDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| valacyclovir group | Experimental | 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. Receives: Drug: Valacyclovir 500 MG |
| Control group | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start25 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Apical AbscessStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mike Sabeti, DDS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266040
- Sponsor's protocol ID
- Valacyclovir
- Status last verified
- May 2025
- First submitted
- 18 Jan 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Herpesviruses as a Causative Factor in Acute Apical Abscess
- ClinicalTrials.gov ID
- NCT05266040
- Acronym / sponsor ID
- Valacyclovir
- Conditions
- Acute Apical Abscess, Pain, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| valacyclovir group | Experimental | Drug: Valacyclovir 500 MG250 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. |
| Control group | Placebo comparator | Drug: Placebo250 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valacyclovir 500 MGConsistent 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. | Drug | valacyclovir group |
| PlaceboConsistent 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. | Drug | Control group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Apical Abscess
Recruiting
Antibacterial Effects of Intracanal Medicaments in Acute Apical Abscesses
Acute Apical Abscess
Not yet recruiting
Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth
Chronic Apical Periodontitis, Necrosis of Pulp
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mike Sabeti, DDS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valacyclovir 500 MG in people with Acute Apical Abscess and Pain, Acute, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mike Sabeti, DDS (415-476-0822, Mike.Sabeti@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pain levels following treatment intervention (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.