Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening

NCT06344195 | Recruiting Phase 4

• 1 other identifier: 2517
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to evaluate the efficacy of valacyclovir in reducing postoperative pain following emergency chamber opening for acute apical abscess . There will be 82 participants, (41 in each group) Group A will receive Valacyclovir Group B will receive standard treatment i.e. Naproxen Sodium. Pain level will be assessed by using Numeric rating scale for 6 days

Conditions

Acute Apical Abscess

Keywords

Acute Apical Abscess; Valacyclovir Monotherapy; Antiviral drug therapy; Emergency chamber opening; Dental Pain

Outcome Measures

Primary Outcomes (1)

• Changes in pain score using Numeric Rating Scale (NRS)

  NRS measures the pain extremes between 0-10 (0=no pain while 10= extreme pain)

  6 days

Study Arms (2)

Valacyclovir Group

EXPERIMENTAL

participants will be given prescription of valacyclovir (2g immediate dose followed by 500mg 2 times daily for 3 days) along with the analgesic, Naproxen sodium, 550mg (SOS, if needed) Data will be recorded daily for 6 days

Drug: Valacyclovir 500 mg

Control Group

ACTIVE COMPARATOR

this is control group and is prescribed with analgesic, Naproxen sodium, 550mg (SOS, if needed) only

Drug: Naproxen Sodium 550mg

Interventions

Valacyclovir 500 mg DRUG

Valtrex 2g immediate dose followed by 500mg 2 times daily for 3 days along with the analgesic (SOS, if needed) for 6 days

Also known as: Valtrex 500mg, Naproxen Sodium 550mg (SOS)

Valacyclovir Group

Naproxen Sodium 550mg DRUG

550mg (as needed, SOS) for 6 days

Also known as: Synflex 550mg

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Age ≥18 years old
• Healthy patient American Society of Anesthesiologists (ASA) class l and ll.
• Patients having clinical evidence of pulp necrosis and acute apical abscess with radiographic signs of periapical disease.
• to 3 as Mild pain. 4 to 6 as moderate pain. 7 to 10 as severe pain.

You may not qualify if:

• Patient currently on antibiotics or antivirals
• Smokers
• Unusual tooth anatomy or inaccurate diagnosis
• Pregnant or nursing mothers
• Patients allergic to valacyclovir

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dr. Yumna Shaheen Ali

Karachi, Sindh, 75290, Pakistan

RECRUITING

MeSH Terms

Conditions

Toothache

Interventions

Valacyclovir; Naproxen

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; 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; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Dr. Yumna Shaheen Ali

  DUHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Yumna Shaheen Ali

CONTACT

03321349223; yumna.shaheen@duhs.edu.pk

Dr. Fazal-ur-Rehman Qazi

CONTACT

02138771111; qazi.rehman@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: March 27, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

PA (1)