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.

NCT ID: NCT07275710

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-02-01

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Brufen

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Brufen and alprazolam

Intervention Type: COMBINATION_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

Interventions

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

Intervention Type: COMBINATION_PRODUCT

Brufen

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi

OTHER

Sponsor Role: lead

Responsible Party

Tahreem Qureshi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Armed Forces Post Graduate Medical Institute

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

tahreem qureshi

Role: CONTACT

tahreemqureshi97@gmail.com

0333-0209209

Facility Contacts

G1 training

Role: primary

admin@afpgmi.edu.pk

05156131187

References

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.

Reference Type: BACKGROUND

PMID: 25489429 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

OD2025-PAIN-01

Identifier Type: -

Identifier Source: org_study_id