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CompletedNCT07014397Updated Jun 11, 2025

Effect of Valaciclovir on Inter-Appointment Pain in Endodontic Treatment of Necrotic Teeth

An interventional study of Valacyclovir and Placebo in Symptomatic Apical Periodontitis, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Nov 2024, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Symptomatic Apical Periodontitis

Keywords

  • symptomatic apical periodontitis (SAP)
  • herpes viruse
  • pain
  • valacyclovir
03

In context

Periodontitis

1,634 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 38 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Placebo comparator
    placebo group

    Drug: Placebo

  • Experimental
    valacyclovir group

    Drug: Valacyclovir

Interventions

  • DrugValacyclovir

    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

  • DrugPlacebo

    The control group received a placebo identical in appearance and administration schedule

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6, 24, and 48 hours post-treatment

Secondary outcomes

  1. Proportion of participants requiring ibuprofen as rescue analgesic

    Time frame: Within 48 hours post-treatment

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Study locations

1 site
  • Tehran University of Medical Sciences, School of Dentistry
    Tehran, 1439955991, Iran, Islamic Republic of
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07014397
Lead sponsor
Tehran University of Medical Sciences
Responsible party
Sponsor
First posted
Jun 11, 2025
Start date
Nov 1, 2024
Primary completion
Mar 22, 2025
Completion
Mar 26, 2025
Last update
Jun 11, 2025

Study contacts

Adnaninia, DDS
principal investigator · Tehran University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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