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

Not Applicable

Completed

• Conditions: Symptomatic Apical Periodontitis
• Interventions: Drug: Placebo; Drug: Valacyclovir

• Registration Number: NCT07014397
• Lead Sponsor: Tehran University of Medical Sciences

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-11-01
• Primary Completion: 2025-03-22
• Study Completion: 2025-03-26
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	-
valacyclovir group	Valacyclovir	-

Primary Outcome Measures

Name	Time	Method
Pain intensity measured by Visual Analog Scale (VAS)	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants requiring ibuprofen as rescue analgesic	Within 48 hours post-treatment

Trial Locations

Locations (1)

Tehran University of Medical Sciences, School of Dentistry; 🇮🇷 Tehran, Iran, Islamic Republic of