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

NCT ID: NCT07014397

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-03-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

valacyclovir group

Group Type: EXPERIMENTAL

Valacyclovir

Intervention Type: 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

Interventions

Valacyclovir

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adnaninia, DDS

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

Tehran University of Medical Sciences, School of Dentistry

Tehran, , Iran

Countries

Iran

Other Identifiers

IR.TUMS.DENTISTRY.REC.1403.045

Identifier Type: -

Identifier Source: org_study_id