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Clinical Trials/NCT07275710
NCT07275710
Not yet recruiting
Not Applicable

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

Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi1 site in 1 country110 target enrollmentStarted: February 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
Enrollment
110
Locations
1
Primary Endpoint
pain levels

Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

brufen

Active Comparator

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.

Intervention: Brufen (Drug)

alprazolam

Active Comparator

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.

Intervention: Brufen and alprazolam (Combination Product)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tahreem Qureshi

Principal Investigator

Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi

Study Sites (1)

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