Comparison of Different Intracanal Medicaments on Post-operative Pain in Teeth With Symptomatic Apical Periodontitis: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Post-operative Pain Intensity Measured Using the Wong-Baker FACES Pain Rating Scale (WFPRS)
研究概览
简要总结
Comparison of different intracanal medicaments during root canal treatment to assess their effect on post-operative pain in teeth with Symptomatic Apical Periodontitis
详细描述
Pain is the most common clinical symptom associated with endodontic treatment. Symptomatic apical periodontitis (SAP) results in significant post-operative discomfort due to microbial invasion and inflammatory changes in periapical tissues. Intracanal medicaments are used to reduce microbial load and inflammation between treatment appointments, potentially reducing post-treatment pain. This study investigates the comparative effectiveness of three commonly used intracanal medicaments in reducing pain following biomechanical preparation:
Group 1: Calcium hydroxide (CH)
Group 2: Chlorhexidine gel (CHX 2%)
Group 3: Modified Triple Antibiotic Paste (TAP) - a combination of ciprofloxacin, clindamycin, and metronidazole in 1:1:1 ratio
A total of 480 participants with single-rooted teeth diagnosed with symptomatic apical periodontitis will be randomly assigned into three groups (160 in each group). Endodontic treatment will be performed by a single operator under standard protocols. No systemic analgesics or antibiotics will be prescribed. Pain assessment will be done using the Wong-Baker FACES Pain Rating Scale (0-10), and recorded at baseline (0 h), 6 h, 24 h, and 48 h after treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single rooted teeth (Anterior or posterior)
- •Teeth with acute symptomatic apical periodontitis
排除标准
- •Non-restorable teeth, presence of endo-perio lesions, teeth with acute or chronic apical abcess, teeth with internal/external root resorption
- •Teeth with anatomical difficulties like open apices, calcified canals, dilacerations
- •Patients with parafunctional habits
- •Patients who were allergic to medications that were used in the study
- •Patients who were taking medicines that could influence pain perception
- •Patients that had any serious medical illness or with systemic disorders
研究组 & 干预措施
Calcium Hydroxide group
Participants in this group will receive 20% calcium hydroxide paste as the intracanal medicament after root canal instrumentation. The medicament will be placed using a Lentulo spiral, excess removed from the chamber, and the tooth sealed with glass ionomer cement. Pain will be assessed at 0, 6, 24, and 48 hours postoperatively.
干预措施: Calcium Hydroxide (20%) (Drug)
Chlorhexidine group
Participants in this group will receive 2% chlorhexidine gel as the intracanal medicament following canal preparation. It will be placed with a Lentulo spiral and sealed in the same manner. Postoperative pain will be evaluated at the same intervals.
干预措施: Chlorhexidine Gel (2%) (Drug)
Modified triple antibiotic paste
Participants in this group will receive a modified triple antibiotic paste made from ciprofloxacin, metronidazole, and clindamycin in a 1:1:1 ratio by weight. The paste will be placed inside the canal using a Lentulo spiral and sealed as per protocol. Pain will be recorded at 0, 6, 24, and 48 hours post-treatment.
干预措施: Modified Triple Antibiotic Paste (Drug)
结局指标
主要结局
Post-operative Pain Intensity Measured Using the Wong-Baker FACES Pain Rating Scale (WFPRS)
时间窗: At baseline (0 hours), 6 hours, 24 hours, and 48 hours post-operatively
Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale (WFPRS), a validated 6-point facial expression scale. The scale ranges from 0 (no pain) to 10 (worst pain), with corresponding facial images used to help patients subjectively rate their pain. This tool will be used during follow-up calls to determine the patient's level of pain after root canal instrumentation and medicament placement. Units of Measurement: Score range: 0-10 (intervals of 2)
次要结局
未报告次要终点
研究者
fatimaharshad
Principal investigator
College of Physicians and Surgeons Pakistan