Clinical and Radiographic Comparative Evaluation of Healing of Periapical Lesion Using Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide When Used as a Root Canal Disinfectant- An In Vivo Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- healing of periapical lesion
研究概览
简要总结
Investigators observed the clinical and radiographic healing of periapical lesion using Chitosan mixed with calcium hydroxide and compared it with triple antibiotic paste when used as intracanal medicament in 3months, 6 months and 12 months.
详细描述
Aim: To evaluate and compare the healing of periapical lesions using chitosan mixed with calcium hydroxide or Triple Antibiotic Paste at 3,6 and 12 months.
Methodology:
20 adult patients having periapical lesions in single rooted teeth were selected in this study after being assessed using the PAI index. Patients were randomly assigned to: Group - I (n=10) Chitosan with Ca (OH)2 and Group -II (n=10) Triple Antibiotic paste (TAP)
After access opening and cleaning and shaping were done in the first visit, the pertinent intracanal medicaments were placed depending on the patient group. After 4 weeks, on the second visit, the medicament was removed andobturation was done in the asymptomatic teeth. Both clinical and radiographic endodontic evaluation was done at 0, 3, 6 and 12months using the same parameters.
Radiographic evaluation was done using the PAI Index and was compared at 0, 3, 6, and 12 months after treatment, Z Test.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 18 and 40 years Periapical lesion (not more than 5mm) radiographically.on single rooted teeth
- •Roots with closed apex.
- •Systemically healthy patients.
排除标准
- •All patients who respond positive to allergic patch test [triple antibiotic paste] and drugs.
- •Teeth with previous endodontic therapy performed.
- •Patients with a history of any systemic diseases.
- •Pregnant and lactating women.
- •Tooth associated with vertical root fracture and coronal perforation.
- •Tooth affected with calcific degeneration.
- •Presence of external or internal root resorption.
- •Blunderbuss apex.
研究组 & 干预措施
Chitosan calcium hyroxide paste
after the access preparation and cleaning and shaping, chitosan calcium hydroxide paste will be placed in the canal and kept for 4 weeks.
干预措施: root canal treatment and intracanal medicament (Drug)
triple antibiotic paste
after the access preparation and cleaning and shaping, ciprofloxacin metronidazole minocycline paste will be :placed in the canal and kept for 4 weeks.
干预措施: root canal treatment and intracanal medicament (Drug)
结局指标
主要结局
healing of periapical lesion
时间窗: change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months
the periapical status will be assessed by using the periapical index \[PAI\] using radiographs and scoring was done according to following scoring index as 1. Normal periapical structures 2. Small changes in bone structure 3. Changes in bone structure with some mineral loss 4. Periodontitis with well-defined radiolucent area 5. Severe periodontitis with exacerbating features
次要结局
- patient pain perception(3months, 6months and 12 months)
研究者
Soumya Shetty
professor
Dr. D. Y. Patil Dental College & Hospital