Symptomatic Apical Periodontitis
Conditions
Keywords
symptomatic apical periodontitis (SAP), herpes viruse, pain, valacyclovir
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).
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
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Proportion of participants requiring ibuprofen as rescue analgesic | Within 48 hours post-treatment |
Countries
Iran
Outcome results
None listed