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

April 8, 2024 updated by: Yumna Shaheen, Dow University of Health Sciences

Valacyclovir Monotherapy in Pain Management of Acute Apical Abscesses After Performing Emergency Chamber Opening; A Randomized Clinical Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

Acute apical abscess is an inflammatory reaction to pulpal infection and necrosis characterized by rapid onset, spontaneous pain, extreme tenderness of the tooth.. Recently, it has been hypothesized that Herpesvirus infection can contribute to the pathogenesis of apical periodontitis. In symptomatic forms of apical periodontitis, the etiology can be same as it is for marginal periodontitis.

OBJECTIVE:

The aim of this study is to test the valacyclovir treatment on patients with acute apical abscess, as it might help reducing pain and the need for analgesics

METHODOLOGY:

The study will be conducted by the principal investigator, a co-investigator, and a research assistant. Patients will be recruited in the study from the Operative Dentistry outpatient department, Dr. Ishrat ul Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences. The study includes 82 patients, who will be equally divided into two groups. Group A would be Valacyclovir Group (41 patients) and Group B Control Group (41 patients). All patients must have pulp necrosis and acute apical abscess. Patients should have moderate to severe pain according to NRS-11 pain assessment scale. It measures the pain extremes between 0-10 (0=no pain while 10= extreme pain). Patients with moderate to severe pain levels i.e., >4 NRS will be the candidate for this study. All patients will be consented, educated and calibrated on numeric rating scale of pain. All the potential candidates will be given emergency treatment by performing chamber opening and pulpectomy. After performing initial treatment patients in valacyclovir group will be advised to take valacyclovir (2g immediate dose followed by 500mg 2 times daily for 3 days) along with the analgesic (SOS, if needed). The control will be prescribed with analgesic, Naproxen Sodium550mg for 3 days (if needed). Baseline for the study would be day 1 (start of medication). A research assistant will phone the study participants daily till 6 days to evaluate pain according to numeric rating scale and analgesic used.

On the first day, patient will be examined. If the patient fulfils inclusion criteria, he or she will be provided with the emergency chamber opening and pulpectomy. Half patients will be given prescription of valacyclovir (2g immediate dose followed by 500mg 2 times daily for 3 days) along with the analgesic (SOS, if needed). The other half will be control group and prescribed with analgesic (SOS, if needed) only. A research assistant will phone the study patients at a preset time daily for 6 days to evaluate,

  1. Pain level according to numeric rating scale (NRS)
  2. Analgesic used Difference in pain relief between valacyclovir and control group will be measured and daily consumption of analgesics will be evaluated at the end of 6-day study

STATISTICAL ANALYSIS:

The statistician will analyze the data by applying Mann Whitney test which will assess the daily difference in pain levels and intake of analgesics between the valacyclovir group and control group. The Friedman test will be applied to analyze the differences in repeated measures between the valacyclovir and control group.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

  • Main inclusion criteria is that patient should have moderate to severe pain, it can be calculated as:

    1 to 3 as Mild pain. 4 to 6 as moderate pain. 7 to 10 as severe pain.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Valacyclovir Group
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
Valtrex 2g immediate dose followed by 500mg 2 times daily for 3 days along with the analgesic (SOS, if needed) for 6 days
Other Names:
  • Valtrex 500mg
  • Naproxen Sodium 550mg (SOS)
Active Comparator: Control Group
this is control group and is prescribed with analgesic, Naproxen sodium, 550mg (SOS, if needed) only
Drug: Naproxen Sodium 550mg
550mg (as needed, SOS) for 6 days
Other Names:
  • Synflex 550mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pain score using Numeric Rating Scale (NRS)
Time Frame: 6 days
NRS measures the pain extremes between 0-10 (0=no pain while 10= extreme pain)
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesic was needed or not
Time Frame: 6 days
both groups will be assessed for intake of analgesic if taken
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Dr. Yumna Shaheen Ali, DUHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2517

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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