Acute Apical AbscessPhase 4AntiviralNCT06344195
Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening
A Phase 4 study testing Valacyclovir 500 mg and Naproxen Sodium 550mg in people with Acute Apical Abscess, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This study is aimed to evaluate the efficacy of valacyclovir in reducing postoperative pain following emergency chamber opening for acute apical abscess . There will be 82 participants, (41 in each group) Group A will receive Valacyclovir Group B will receive standard treatment i.e. Naproxen Sodium. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Apical Abscess
- What is being tested?
- Valacyclovir 500 mg and Naproxen Sodium 550mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Mar 2024to May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Age ≥18 years old
- Healthy patient American Society of Anesthesiologists (ASA) class l and ll.
- Patients having clinical evidence of pulp necrosis and acute apical abscess with radiographic signs of periapical disease.
- Main inclusion criteria is that patient should have moderate to severe pain, it can be calculated as:
- 1 to 3 as Mild pain. 4 to 6 as moderate pain. 7 to 10 as severe pain.
Who cannot join
- Patient currently on antibiotics or antivirals
- Smokers
- Unusual tooth anatomy or inaccurate diagnosis
- Pregnant or nursing mothers
- Patients allergic to valacyclovir
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dr. Yumna Shaheen Ali
Karachi, Sindh, 75290
Dr. Yumna Shaheen Ali, yumna.shaheen@duhs.edu.pk
About this study
Official title: Valacyclovir Monotherapy in Pain Management of Acute Apical Abscesses After Performing Emergency Chamber Opening; A Randomized Clinical Trial
This study is aimed to evaluate the efficacy of valacyclovir in reducing postoperative pain following emergency chamber opening for acute apical abscess .
There will be 82 participants, (41 in each group) Group A will receive Valacyclovir Group B will receive standard treatment i.e. Naproxen Sodium. Pain level will be assessed by using Numeric rating scale for 6 days
Read the detailed description
BACKGROUND:
Acute apical abscess is an inflammatory reaction to pulpal infection and necrosis characterized by rapid onset, spontaneous pain, extreme tenderness of the tooth.. Recently, it has been hypothesized that Herpesvirus infection can contribute to the pathogenesis of apical periodontitis. In symptomatic forms of apical periodontitis, the etiology can be same as it is for marginal periodontitis.
OBJECTIVE:
The aim of this study is to test the valacyclovir treatment on patients with acute apical abscess, as it might help reducing pain and the need for analgesics
METHODOLOGY:
The study will be conducted by the principal investigator, a co-investigator, and a research assistant. Patients will be recruited in the study from the Operative Dentistry outpatient department, Dr. Ishrat ul Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences. The study includes 82 patients, who will be equally divided into two groups. Group A would be Valacyclovir Group (41 patients) and Group B Control Group (41 patients). All patients must have pulp necrosis and acute apical abscess. Patients should have moderate to severe pain according to NRS-11 pain assessment scale. It measures the pain extremes between 0-10 (0=no pain while 10= extreme pain). Patients with moderate to severe pain levels i.e., >4 NRS will be the candidate for this study. All patients will be consented, educated and calibrated on numeric rating scale of pain. All the potential candidates will be given emergency treatment by performing chamber opening and pulpectomy. After performing initial treatment patients in valacyclovir group will be advised to take valacyclovir (2g immediate dose followed by 500mg 2 times daily for 3 days) along with the analgesic (SOS, if needed). The control will be prescribed with analgesic, Naproxen Sodium550mg for 3 days (if needed). Baseline for the study would be day 1 (start of medication). A research assistant will phone the study participants daily till 6 days to evaluate pain according to numeric rating scale and analgesic used.
On the first day, patient will be examined. If the patient fulfils inclusion criteria, he or she will be provided with the emergency chamber opening and pulpectomy. Half patients will be given prescription of valacyclovir (2g immediate dose followed by 500mg 2 times daily for 3 days) along with the analgesic (SOS, if needed). The other half will be control group and prescribed with analgesic (SOS, if needed) only. A research assistant will phone the study patients at a preset time daily for 6 days to evaluate,
- Pain level according to numeric rating scale (NRS)
- Analgesic used Difference in pain relief between valacyclovir and control group will be measured and daily consumption of analgesics will be evaluated at the end of 6-day study
STATISTICAL ANALYSIS:
The statistician will analyze the data by applying Mann Whitney test which will assess the daily difference in pain levels and intake of analgesics between the valacyclovir group and control group. The Friedman test will be applied to analyze the differences in repeated measures between the valacyclovir and control group.
- Conditions
- Acute Apical Abscess
- Being tested
- Valacyclovir 500 mg, Naproxen Sodium 550mg
- Keywords
- Acute Apical Abscess, Valacyclovir Monotherapy, Antiviral drug therapy, Emergency chamber opening, Dental Pain
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir 500 mgDrug
Also called Valtrex 500mg, Naproxen Sodium 550mg (SOS)
Valtrex 2g immediate dose followed by 500mg 2 times daily for 3 days along with the analgesic (SOS, if needed) for 6 days
Naproxen Sodium 550mgDrug
Also called Synflex 550mg
550mg (as needed, SOS) for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Valacyclovir Group | Experimental | participants will be given prescription of valacyclovir (2g immediate dose followed by 500mg 2 times daily for 3 days) along with the analgesic, Naproxen sodium, 550mg (SOS, if needed) Data will be recorded daily for 6 days Receives: Drug: Valacyclovir 500 mg |
| Control Group | Active comparator | this is control group and is prescribed with analgesic, Naproxen sodium, 550mg (SOS, if needed) only Receives: Drug: Naproxen Sodium 550mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain score using Numeric Rating Scale (NRS)
NRS measures the pain extremes between 0-10 (0=no pain while 10= extreme pain)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start27 Mar 2024
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yumna Shaheen, Dow University of Health Sciences
- Investigators
- Dr. Yumna Shaheen Ali, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344195
- Sponsor's protocol ID
- 2517
- Acronym
- Antiviral
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valacyclovir Monotherapy in Pain Management of Acute Apical Abscesses After Performing Emergency Chamber Opening; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06344195
- Acronym / sponsor ID
- Antiviral / 2517
- Conditions
- Acute Apical Abscess
- Keywords
- Acute Apical Abscess, Valacyclovir Monotherapy, Antiviral drug therapy, Emergency chamber opening, Dental Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 3 Apr 2024 (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.
This study is aimed to evaluate the efficacy of valacyclovir in reducing postoperative pain following emergency chamber opening for acute apical abscess .
There will be 82 participants, (41 in each group) Group A will receive Valacyclovir Group B will receive standard treatment i.e. Naproxen Sodium. Pain level will be assessed by using Numeric rating scale for 6 days
Detailed description
BACKGROUND:
Acute apical abscess is an inflammatory reaction to pulpal infection and necrosis characterized by rapid onset, spontaneous pain, extreme tenderness of the tooth.. Recently, it has been hypothesized that Herpesvirus infection can contribute to the pathogenesis of apical periodontitis. In symptomatic forms of apical periodontitis, the etiology can be same as it is for marginal periodontitis.
OBJECTIVE:
The aim of this study is to test the valacyclovir treatment on patients with acute apical abscess, as it might help reducing pain and the need for analgesics
METHODOLOGY:
The study will be conducted by the principal investigator, a co-investigator, and a research assistant. Patients will be recruited in the study from the Operative Dentistry outpatient department, Dr. Ishrat ul Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences. The study includes 82 patients, who will be equally divided into two groups. Group A would be Valacyclovir Group (41 patients) and Group B Control Group (41 patients). All patients must have pulp necrosis and acute apical abscess. Patients should have moderate to severe pain according to NRS-11 pain assessment scale. It measures the pain extremes between 0-10 (0=no pain while 10= extreme pain). Patients with moderate to severe pain levels i.e., >4 NRS will be the candidate for this study. All patients will be consented, educated and calibrated on numeric rating scale of pain. All the potential candidates will be given emergency treatment by performing chamber opening and pulpectomy. After performing initial treatment patients in valacyclovir group will be advised to take valacyclovir (2g immediate dose followed by 500mg 2 times daily for 3 days) along with the analgesic (SOS, if needed). The control will be prescribed with analgesic, Naproxen Sodium550mg for 3 days (if needed). Baseline for the study would be day 1 (start of medication). A research assistant will phone the study participants daily till 6 days to evaluate pain according to numeric rating scale and analgesic used.
On the first day, patient will be examined. If the patient fulfils inclusion criteria, he or she will be provided with the emergency chamber opening and pulpectomy. Half patients will be given prescription of valacyclovir (2g immediate dose followed by 500mg 2 times daily for 3 days) along with the analgesic (SOS, if needed). The other half will be control group and prescribed with analgesic (SOS, if needed) only. A research assistant will phone the study patients at a preset time daily for 6 days to evaluate,
- Pain level according to numeric rating scale (NRS)
- Analgesic used Difference in pain relief between valacyclovir and control group will be measured and daily consumption of analgesics will be evaluated at the end of 6-day study
STATISTICAL ANALYSIS:
The statistician will analyze the data by applying Mann Whitney test which will assess the daily difference in pain levels and intake of analgesics between the valacyclovir group and control group. The Friedman test will be applied to analyze the differences in repeated measures between the valacyclovir and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valacyclovir Group | Experimental | Drug: Valacyclovir 500 mgparticipants will be given prescription of valacyclovir (2g immediate dose followed by 500mg 2 times daily for 3 days) along with the analgesic, Naproxen sodium, 550mg (SOS, if needed) Data will be recorded daily for 6 days |
| Control Group | Active comparator | Drug: Naproxen Sodium 550mgthis is control group and is prescribed with analgesic, Naproxen sodium, 550mg (SOS, if needed) only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient Age ≥18 years old
- Healthy patient American Society of Anesthesiologists (ASA) class l and ll.
- Patients having clinical evidence of pulp necrosis and acute apical abscess with radiographic signs of periapical disease.
- Main inclusion criteria is that patient should have moderate to severe pain, it can be calculated as:
- 1 to 3 as Mild pain. 4 to 6 as moderate pain. 7 to 10 as severe pain.
Key exclusion criteria (5 listed)
- Patient currently on antibiotics or antivirals
- Smokers
- Unusual tooth anatomy or inaccurate diagnosis
- Pregnant or nursing mothers
- Patients allergic to 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 mgAlso: Valtrex 500mg, Naproxen Sodium 550mg (SOS)Valtrex 2g immediate dose followed by 500mg 2 times daily for 3 days along with the analgesic (SOS, if needed) for 6 days | Drug | Valacyclovir Group |
| Naproxen Sodium 550mgAlso: Synflex 550mg550mg (as needed, SOS) for 6 days | Drug | Control Group |
Primary outcome
Changes in pain score using Numeric Rating Scale (NRS)
Time frame: 6 days
NRS measures the pain extremes between 0-10 (0=no pain while 10= extreme pain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth
Chronic Apical Periodontitis, Necrosis of Pulp
RecruitingPhase 2
Valacyclovir in Pain Management of Acute Apical Abscesses
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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. This study is not recruiting at the moment.
Dr. Yumna Shaheen Ali principal investigator
DUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valacyclovir 500 mg and Naproxen Sodium 550mg in people with Acute Apical Abscess, run by Dow University of Health Sciences at 1 site in Pakistan.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. 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 Pakistan. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Yumna Shaheen Ali (03321349223, yumna.shaheen@duhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain score using Numeric Rating Scale (NRS) (time frame: 6 days). 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 10 Apr 2024.