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临床试验/NCT07275710
NCT07275710招募中不适用

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

Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi3 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年7月30日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
110
试验地点
3
主要终点
pain levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Brufen and alprazolam (Combination Product)

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.

干预措施: Brufen (Drug)

结局指标

主要结局

pain levels

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tahreem Qureshi

Principal Investigator

Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi

研究点 (3)

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