A Phase 4 interventional study of Valacyclovir 500 mg and Naproxen Sodium 550mg in Acute Apical Abscess, sponsored by Dow University of Health Sciences. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Dow University of Health Sciences · Phase 4, Interventional, and Treatment
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
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,
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.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's planned enrollment of 82 is close to the median of 84 across 123 interventional studies indexed under Toothache.
Browse Toothache studies →Dow University of Health Sciences is the lead sponsor of 179 studies on the registry; 34 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
this is control group and is prescribed with analgesic, Naproxen sodium, 550mg (SOS, if needed) only
Drug: Naproxen Sodium 550mg
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)
550mg (as needed, SOS) for 6 days
Also known as: Synflex 550mg
Changes in pain score using Numeric Rating Scale (NRS)
NRS measures the pain extremes between 0-10 (0=no pain while 10= extreme pain)
Time frame: 6 days
Started Mar 2024 (actual). Primary completion is estimated for Apr 2024, 1 month after the start.
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Studies of the drug tested here: Valacyclovir
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