Comparative Analysis of Postoperative Pain in Symptomatic Irreversible Pulpitis Teeth Following Single Cone Obturation Using Three Different Sealers: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Post-Endodontic Pain Intensity
研究概览
简要总结
The goal of this clinical trial is to compare post-treatment pain after root canal therapy in adults with irreversible pulpitis using different root canal sealers. The study will also evaluate the need for pain medication after treatment.
The main questions this study aims to answer are:
Does the type of root canal sealer affect the intensity of pain after treatment?
Does the type of sealer influence the number of analgesic tablets taken by participants?
How does pain change over time after treatment with different sealers?
Researchers will compare two bioceramic sealers (EndoSeal TCS and NeoSeal) with a resin-based sealer (AH Plus) to determine their effects on post-endodontic pain.
Participants will:
Receive root canal treatment using one of the study sealers
Report their pain intensity at specific time points after treatment
Record the number of analgesic tablets taken during the follow-up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 60 years
- •Adequate oral and dental hygiene
- •Prolonged positive response to cold test and electric pulp testing
- •Clinical diagnosis of symptomatic irreversible pulpitis and symptomatic apical periodontitis in a first or second molar (maxillary or mandibular)
- •Pulp exposure during caries removal accompanied by severe and profuse hemorrhage
- •No radiographic evidence of periapical lesions
- •Teeth with adequate restorative potential
- •Absence of periodontal disease
排除标准
- •Teeth that are non-restorable
- •Presence of endodontic-periodontal (endo-perio) lesions
- •Teeth with radiographic evidence of periapical lesions
- •Teeth with internal or external root resorption
- •Patients with systemic diseases classified as ASA II or higher
- •Patients with a history of migraine
- •Teeth with over-obturation or under-obturation greater than 2 mm from the radiographic apex
- •Patients taking anti-anxiety medications
- •Procedural duration exceeding two hours
- •Known allergy to materials used in root canal treatment, including local anesthetics
研究组 & 干预措施
EndoSeal TCS
Participants receive single-visit root canal treatment using the bioceramic sealer EndoSeal TCS with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals
干预措施: Endoseal TCS (Procedure)
NeoSealer
Participants receive single-visit root canal treatment using the bioceramic sealer NeoSealer with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals.
干预措施: Neosealer (Procedure)
AH Plus
Participants receive single-visit root canal treatment using the resin-based sealer AH Plus with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals
干预措施: AH Plus (Procedure)
结局指标
主要结局
Post-Endodontic Pain Intensity
时间窗: Pain will be assessed at 6, 12,18, 24, and 48 hours post-treatment
Pain intensity experienced by participants after root canal treatment will be measured using a Visual Analog Scale (VAS; 0-10 numeric rating scale), where: 0 = no pain 10 = worst imaginable pain Higher scores indicate greater pain intensity (worse outcome). Participants will also record the number of analgesic tablets consumed during the first 48 hours after treatment. The maximum VAS pain score recorded during the first 48 hours will be considered the primary outcome
次要结局
- Analgesic Consumption(Within 48 hours post-treatment)