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临床试验/NCT07252258
NCT07252258进行中(未招募)不适用

Comparison of Frequency of Calcium Hydroxide Mixed With 0.2% Chlorhexidine Versus Saline as Intracanal Medicament in Periapical Periodontitis-A Randomized Controlled Trial

Aqsa Afzal1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
80
试验地点
1
主要终点
primary outcome measure

研究概览

简要总结

This randomized controlled trial aims to compare the effectiveness of calcium hydroxide mixed with 0.2% chlorhexidine digluconate versus calcium hydroxide mixed with saline as intracanal medicaments in reducing postoperative pain in patients with apical periodontitis. A total of 80 adult patients with anterior teeth diagnosed with apical periodontitis will be randomly assigned to two equal groups. After standard chemomechanical root canal preparation, Group A will receive calcium hydroxide with saline, while Group B will receive calcium hydroxide with 0.2% chlorhexidine. Postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS) at 12, 24, and 48 hours. The primary outcome is the frequency and severity of pain at 24 hours. Data will be analyzed using chi-square or Fisher's exact test, with a significance level of p < 0.05. The study aims to determine whether the addition of chlorhexidine improves the analgesic and antimicrobial effectiveness of calcium hydroxide during root canal 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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •• Patients age 18 or above 18 year old (to have complete apex formation)
  • •Anterior teeth with apical periodontitis (simple root canal morphology)
  • •Patients whose medical history does not include a history of certain illnesses, such as HIV, heart disease, or epilepsy (conditions that can affect a patient's rate of healing).

排除标准

  • •Patient allergic to chlorhexidine digluconate and Calcium hydroxide assessed by history.
  • •Tooth having necrotic pulp on radiographic examination and electric pulp tester.
  • •Multiple rooted teeth.
  • •Previously root canal treated tooth because of procedural errors and periapical infection.

研究组 & 干预措施

Calcium Hydroxide + Saline

Placebo Comparator

Participants in this arm will receive intracanal medicament consisting of calcium hydroxide mixed with normal saline after standard chemomechanical root canal preparation. Temporary restoration will be placed, and postoperative pain will be assessed at designated intervals

干预措施: Calcium Hydroxide + Normal Saline (Drug)

Calcium Hydroxide + 0.2% Chlorhexidine

Experimental

Participants in this arm will receive intracanal medicament consisting of calcium hydroxide mixed with 0.2% chlorhexidine digluconate following standard root canal procedures. Temporary restoration will be placed, and postoperative pain will be evaluated.

干预措施: Calcium Hydroxide + 0.2% Chlorhexidine Digluconate (Drug)

结局指标

主要结局

primary outcome measure

时间窗: 24 hours after placement of intracanal medicament (pain also recorded at 12 and 48 hours, but final outcome measured at 24 hours).

Postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS), where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.

次要结局

未报告次要终点

研究者

发起方
Aqsa Afzal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aqsa Afzal

FAyoub

College of Physicians and Surgeons Pakistan

研究点 (1)

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