Symptomatic Apical PeriodontitisNCT07014397
Effect of Valaciclovir on Inter-Appointment Pain in Endodontic Treatment of Necrotic Teeth
A study testing Valacyclovir in people with Symptomatic Apical Periodontitis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Aim: To investigate the effect of oral valacyclovir on inter-appointment endodontic pain in single-rooted necrotic teeth diagnosed with symptomatic apical periodontitis (SAP). Materials and Methods: This study was a randomized, triple-blind, placebo-controlled clinical trial conducted on 38 teeth. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Symptomatic Apical Periodontitis
- What is being tested?
- Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteIran
- Study dates
- 1 Nov 2024to 26 Mar 2025
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 18 and 60 years of age
- Require primary root canal treatment (RCT) in single-rooted maxillary or mandibular teeth (anterior or posterior)
- Diagnosed with symptomatic apical periodontitis (SAP) with confirmed pulp necrosis
Who cannot join
- Teeth with unrestorable crowns
- Presence of endodontic-periodontal or pure endodontic lesions
- Complex root canal anatomies as defined by the AAE Endodontic Case Difficulty Assessment Form
- Internal or external root resorption
- Calcified canals
- Root canal configuration other than Vertucci's Type I
Show all 16Show fewer
- Pain originating from more than one tooth
- Marginal periodontitis
- Parafunctional habits
- Systemic diseases classified as ASA class II or higher
- Diagnosed migraine or other headache disorders mimicking orofacial pain
- Intellectual or cognitive impairments
- Pregnancy or breastfeeding
- Use of medications affecting pain perception
- Current use of antibiotics or antiviral agents
- Known allergies to study medications
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tehran University of Medical Sciences, School of Dentistry
Tehran, 1439955991
About this study
Official title: Effect of Oral Valaciclovir on Inter- Appointment Endodontic Pain in Single-Rooted Necrotic Teeth With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
Aim: To investigate the effect of oral valacyclovir on inter-appointment endodontic pain in single-rooted necrotic teeth diagnosed with symptomatic apical periodontitis (SAP).
Materials and Methods: This study was a randomized, triple-blind, placebo-controlled clinical trial conducted on 38 teeth. Participants were assigned to intervention or control groups using stratified randomization based on gender and baseline pain severity. Both groups received similar root canal treatment; the only difference was the administration of valacyclovir in the intervention group and placebo in the control group. Patients' pain levels were monitored and recorded at 6, 24, and 48 hours post-treatment using a Visual Analog Scale (VAS), along with their consumption of analgesic (ibuprofen).
- Conditions
- Symptomatic Apical Periodontitis
- Being tested
- Valacyclovir, Placebo
- Keywords
- symptomatic apical periodontitis (SAP), herpes viruse, pain, valacyclovir
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
valacyclovir group received 2 g (two 1 g tablets) one hour prior to treatment, followed by 2 g 12 hours later, and 1 g at both 24 and 36 hours post-treatment
PlaceboDrug
The control group received a placebo identical in appearance and administration schedule
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
| valacyclovir group | Experimental | Not described Receives: Drug: Valacyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a commonly used tool for assessing pain intensity in patients. In this method, the patient is asked to indicate the perceived level of pain on a 10-centimeter horizontal line, where 0 represents "no pain" and 10 denotes "the worst pain imaginable." Based on the scores provided by patients, pain intensity is categorized into three levels: scores from 0 to 3 indicate mild pain, 4 to 7 indicate moderate pain, and 8 to 10 indicate severe pain.
Measured: 6, 24, and 48 hours post-treatment
Secondary outcomes (1)
Proportion of participants requiring ibuprofen as rescue analgesic
Measured: Within 48 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Nov 2024
- Primary completion22 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Apical PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adnaninia, DDS, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014397
- Sponsor's protocol ID
- IR.TUMS.DENTISTRY.REC.1403.045
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Valaciclovir on Inter- Appointment Endodontic Pain in Single-Rooted Necrotic Teeth With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07014397
- Acronym / sponsor ID
- IR.TUMS.DENTISTRY.REC.1403.045
- Conditions
- Symptomatic Apical Periodontitis
- Keywords
- symptomatic apical periodontitis (SAP), herpes viruse, pain, valacyclovir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 22 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 11 Jun 2025 (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.
Aim: To investigate the effect of oral valacyclovir on inter-appointment endodontic pain in single-rooted necrotic teeth diagnosed with symptomatic apical periodontitis (SAP).
Materials and Methods: This study was a randomized, triple-blind, placebo-controlled clinical trial conducted on 38 teeth. Participants were assigned to intervention or control groups using stratified randomization based on gender and baseline pain severity. Both groups received similar root canal treatment; the only difference was the administration of valacyclovir in the intervention group and placebo in the control group. Patients' pain levels were monitored and recorded at 6, 24, and 48 hours post-treatment using a Visual Analog Scale (VAS), along with their consumption of analgesic (ibuprofen).
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 |
|---|---|---|
| placebo group | Placebo comparator | Drug: Placebo |
| valacyclovir group | Experimental | Drug: Valacyclovir |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between 18 and 60 years of age
- Require primary root canal treatment (RCT) in single-rooted maxillary or mandibular teeth (anterior or posterior)
- Diagnosed with symptomatic apical periodontitis (SAP) with confirmed pulp necrosis
Key exclusion criteria (16 listed)
- Teeth with unrestorable crowns
- Presence of endodontic-periodontal or pure endodontic lesions
- Complex root canal anatomies as defined by the AAE Endodontic Case Difficulty Assessment Form
- Internal or external root resorption
- Calcified canals
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 |
|---|---|---|
| Valacyclovirvalacyclovir group received 2 g (two 1 g tablets) one hour prior to treatment, followed by 2 g 12 hours later, and 1 g at both 24 and 36 hours post-treatment | Drug | valacyclovir group |
| PlaceboThe control group received a placebo identical in appearance and administration schedule | Drug | placebo group |
Primary outcome
Pain intensity measured by Visual Analog Scale (VAS)
Time frame: 6, 24, and 48 hours post-treatment
The Visual Analog Scale (VAS) is a commonly used tool for assessing pain intensity in patients. In this method, the patient is asked to indicate the perceived level of pain on a 10-centimeter horizontal line, where 0 represents "no pain" and 10 denotes "the worst pain imaginable." Based on the scores provided by patients, pain intensity is categorized into three levels: scores from 0 to 3 indicate mild pain, 4 to 7 indicate moderate pain, and 8 to 10 indicate severe pain.
1 secondary outcome
Proportion of participants requiring ibuprofen as rescue analgesic
Time frame: Within 48 hours post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Adnaninia, DDS principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valacyclovir in people with Symptomatic Apical Periodontitis, run by Tehran University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 16 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: finished, as of the sponsor's last update on 11 Jun 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 Iran. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured by Visual Analog Scale (VAS) (time frame: 6, 24, and 48 hours post-treatment). 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 11 Jun 2025.