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AzTrials

PainNCT07275710

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.

A study testing Brufen and alprazolam and Brufen in people with Pain, run by Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi at 2 sites in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Pain
What is being tested?
Brufen and alprazolam and Brufen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesPakistan
Study dates
30 Jul 2026to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan2 sites, 2 recruiting
  • Armed Forces Post Graduate Medical Institute

    Rawalpindi, Punjab Province, 46000

    G1 training, 05156131187, admin@afpgmi.edu.pk

    Not yet recruiting
  • Operative Department, Armed Forces Institute of Dentistry CMH Rwp

    Rawalpindi

    Tahreem Qureshi, +923330209209, tahreemqureshi97@gmail.com

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Conditions
Pain
Being tested
Brufen and alprazolam, Brufen
Keywords
post endodontic pain, root canal treatment, alprazolam
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brufen and alprazolamCombination product

    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

  • BrufenDrug

    one group in the study will be prescribed 400mg ibuprofen for management of post endodontic pain after root canal treatment

Study groups in NCT07275710
Study groupRoleWhat they receive
brufenActive comparatorone 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.
Receives: Drug: Brufen
alprazolamActive comparatorsecond 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.
Receives: Combination Product: Brufen and alprazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain levels

    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.

    Measured: 6 hours 12 hours 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study start30 Jul 2026 (estimated)
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07275710
Sponsor's protocol ID
OD2025-PAIN-01
Status last verified
Jul 2026
First submitted
16 Nov 2025
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Baradaran M, Hamidi MR, Moghimi Firoozabad MR, Kazemi S, Ashrafpour M, Moghadamnia AA. Alprazolam role in the analgesic effect of ibuprofen on postendodontic pain. Caspian J Intern Med. 2014 Fall;5(4):196-201.

    PubMed 25489429

Questions about this trial

What is this clinical trial studying?

A study testing Brufen and alprazolam and Brufen in people with Pain, run by Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact tahreem qureshi (0333-0209209, tahreemqureshi97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain levels (time frame: 6 hours 12 hours 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07275710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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