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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.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07275710
Enrollment
110
Registered
2025-12-10
Start date
2026-07-30
Completion date
2027-02-01
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

post endodontic pain, root canal treatment, alprazolam

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.

Interventions

COMBINATION_PRODUCTBrufen 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

DRUGBrufen

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

Sponsors

Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
pain levels6 hours 12 hours 24 hourspatients 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.

Countries

Pakistan

Contacts

CONTACTtahreem qureshi
tahreemqureshi97@gmail.com0333-0209209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026