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

NCT07014397 | Completed

• 1 other identifier: IR.TUMS.DENTISTRY.REC.1403.045
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Symptomatic Apical Periodontitis

Keywords

symptomatic apical periodontitis (SAP); herpes viruse; pain; valacyclovir

Outcome Measures

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.

  6, 24, and 48 hours post-treatment

Secondary Outcomes (1)

• Proportion of participants requiring ibuprofen as rescue analgesic

  Within 48 hours post-treatment

Study Arms (2)

placebo group

PLACEBO COMPARATOR

Drug: Placebo

valacyclovir group

EXPERIMENTAL

Drug: Valacyclovir

Interventions

Valacyclovir DRUG

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

valacyclovir group

Placebo DRUG

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

placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences, School of Dentistry

Tehran, 1439955991, Iran

Location

MeSH Terms

Conditions

Pain

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Adnaninia, DDS

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 11, 2025
• Study Start: November 1, 2024
• Primary Completion: March 22, 2025
• Study Completion: March 26, 2025
• Last Updated: June 11, 2025

Record last verified: 2024-06

Locations

IR (1)