Comparative Evaluation of Hyalone and Calcium Hydroxide on Post-Operative Pain and Periapical Healing in Mandibular Molars Teeth With Necrotic Pulp and Symptomatic Apical Periodontitis .
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- post-operative pain
研究概览
简要总结
This protocol presents a randomized clinical trial comparing Hyalone (hyaluronic acid) with calcium hydroxide as intracanal medicaments in mandibular first molars with necrotic pulp and symptomatic apical periodontitis. The study aims to determine whether Hyalone provides better postoperative pain reduction and periapical healing than calcium hydroxide.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
- •Age range is between 20 to 40 years.
- •Patients have restorable permanent mandibular first molars (mesial root type III and distal canal type III) that were diagnosed necrotic with symptomatic apical periodontitis with small to moderate periapical lesion less that 5 mm according to CBCT-PAI in highest diameter at any axis in CBCT).
- •Positive patient's acceptance for participating in the study.
- •Patients able to sign informed consent
排除标准
- •• Medically compromised patients.
- •Pregnant or lactating females.
- •Psychologically disturbed patients.
- •Patients with a history of allergy to any medication used in the study were excluded.
- •Teeth that have:
- •Periodontally affected with grade 2 or 3 mobility.
- •Not restorable teeth.
- •Abnormal anatomy and calcified canals.
- •Previous root canal treatment.
研究组 & 干预措施
calcium hydroxide intracanal medication
干预措施: Calcium Hydroxide (Ca(OH)2) Intracanal Medication (Drug)
Hyalone Intracanal Medication
干预措施: Hyalone (Drug)
结局指标
主要结局
post-operative pain
时间窗: 6 hours,12hours,24 hours, 72 hours & 1week
Postoperative pain will be assessed using the Modified Visual Analogue Scale (mVAS), an 11-point numeric scale with a minimum score of 0 and a maximum score of 10, accompanied by corresponding facial-expression icons at each level. Higher scores indicate worse pain: a score of 0 represents "no pain" and a score of 10 represents "the worst pain imaginable." Scores will be categorized as no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10). Each participant will record pain intensity in a standardized pain diary at each designated time point following intracanal medicament placement. Mean pain scores will be compared between the calcium hydroxide (control) and Hyalone (intervention) groups at each time point.
次要结局
- periapical healing(6months & 12 months)
- preapical healing(6 month and 12 month)
研究者
Omar Tarek Idrees Ewis
post graduate student
Future University in Egypt