Role of Alprazolam in Management of Post Endodontic Pain After Single Visit Root Canal Treatment. To Compare Mean Pain Score Between Two Group of Participants Undergoing Post Operative Pain Management After Single Visit Root Canal Treatment: NSAIDs Alone and a Combination of NSAIDs and Alprazolam.

July 26, 2026 updated by: Tahreem Qureshi, Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi

Role of Alprazolam in Management of Post Endodontic Pain After Single Visit Root Canal Treatment

To compare mean pain score between two group of participants undergoing post operative pain management after single visit root canal treatment: one group receiving NSAIDs alone and the other receiving a combination of NSAIDs and an anxiolytic medication i.e alprazolam.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled clinical trial is designed to compare postoperative pain levels following single-visit root canal treatment in patients receiving two different analgesic regimens: ibuprofen alone or a combination of ibuprofen and alprazolam.

Eligible patients will be screened through detailed medical and dental histories, clinical examinations, and necessary diagnostic tests, including periapical radiographs. Participants meeting the inclusion criteria will be divided into two equal groups using a scientific random number table to ensure unbiased allocation. Matching will be performed based on relevant variables such as age, gender, and tooth location to minimize confounding factors.

Root canal therapy will be carried out in a single visit under local anesthesia (Septodent, Lignospan Special; 2% lignocaine hydrochloride with 1:80,000 adrenaline) and rubber dam isolation. The working length will be determined 1 mm short of the radiographic apex using an apex locator (DENTSPLY Maillefer, Denta Port ZX) and verified radiographically.

Canal instrumentation will be performed with ProTaper Universal hand files (DENTSPLY Sirona) under copious irrigation with 5.25% sodium hypochlorite solution (Henry Schein). Instrumentation will proceed up to F2 ProTaper size. Canal patency will be maintained using a #10 K-file (DENTSPLY Maillefer) between each instrument change. A final rinse with 17% EDTA (ERKAMED Endo-Prep Gel) will be used to remove the smear layer.

After chemo-mechanical preparation, canals will be dried with sterile paper points (Sure-Endo). Obturation will be performed using the single-cone technique with F2 gutta-percha points (Bio GP Points, Sure-Endo) and endodontic sealer (President Dental Germany, Endoplus). The master cone position will be confirmed radiographically. Sealer placement will be accomplished with a lentulospiral (DENTSPLY Sirona) in a slow-speed handpiece. All clinical procedures will be completed by a single operator in one visit. After obturation, the access cavity will be sealed with a 4 mm thickness of temporary filling material (DETAX, Fermin). Patients will be recalled after one week for permanent restoration.

Blinding

To minimize bias, blinding will be implemented at multiple levels:

  • Patient Blinding: Patients will be unaware of the specific drug comparison and will be informed only that the study evaluates postoperative pain following root canal therapy.
  • Operator Blinding: A single operator will perform all treatments but will not participate in postoperative pain assessment.
  • Outcome Assessor Blinding: The evaluator responsible for collecting pain scores and performing statistical analysis will be blinded to group assignments.

Intervention Groups

Following completion of obturation and placement of the temporary restoration, patients will be randomly assigned to one of two groups:

  • Group 1: Ibuprofen 400 mg (Abbott Brufen)
  • Group 2: Ibuprofen 400 mg (Abbott Brufen) + Alprazolam 0.5 mg (Hilton Pharma Alp)

Pain Assessment

Participants will be provided with a pain diary containing a 10 cm Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). They will record their pain intensity at 6, 12, and 24 hours after treatment. Pain diaries will be collected during the one-week follow-up visit. Data will be used to compare mean VAS scores between groups to evaluate the efficacy of the two analgesic regimens.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

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 Locations

  • Pakistan
      • Rawalpindi, Pakistan
        • Recruiting
        • Operative Department, Armed Forces Institute of Dentistry CMH Rwp
        • Contact:
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 46000
        • Not yet recruiting
        • Armed Forces Post Graduate Medical Institute
        • Contact:

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients aged between 18-60 years
  • healthy patients with ASA classification I and II
  • Teeth with symptomatic irreversible pulpitis

Exclusion Criteria:

  • patient suffering from systemic disease that requires antibiotics
  • pregnant or lactating mothers
  • teeth with periapical radiolucency
  • teeth with severe periodontitis
  • patients who have taken analgesics 12 hours prior to procedure
  • patients already taking benzodiadepines

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: brufen
one group in the study will be prescribed 400mg ibuprofen tablet for management of post endodontic pain after root canal treatment and patient will be asked to score their pain level at 6, 12 and 24 hours on visual analogue scale.
Drug: Brufen
one group in the study will be prescribed 400mg ibuprofen for management of post endodontic pain after root canal treatment
Active Comparator: alprazolam
second group in the study will be prescribed 0.5mg alp tablet for management of post endodontic pain after root canal treatment and patient will be asked to score their pain level at 6, 12 and 24 hours on visual analogue scale.
Combination product: Brufen and alprazolam
second group in the study will be prescribed 400mg ibuprofen and 0.5mg alp tablet for management of post endodontic pain after root canal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain levels
Time Frame: 6 hours 12 hours 24 hours

patients will be randomly assigned to one of two groups:

  • Group 1: Ibuprofen 400 mg (Abbott Brufen)
  • Group 2: Ibuprofen 400 mg (Abbott Brufen) + Alprazolam 0.5 mg (Hilton Pharma Alp)

Pain Assessment

Participants will be provided with a pain diary containing a 10 cm Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). They will record their pain intensity at 6, 12, and 24 hours after treatment. Pain diaries will be collected during the one-week follow-up visit. Data will be used to compare mean VAS scores between groups to evaluate the efficacy of the two analgesic regimens.
6 hours 12 hours 24 hours

Collaborators and Investigators

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

Sponsor

Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 30, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OD2025-PAIN-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the study does not include plans or infrastructure for secure long-term data storage, de-identification, and controlled access needed to protect participant privacy. Additionally, the dataset is small, and disclosure may increase the risk of re-identification. Summary results will be made available as required.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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