The Effect of Final Irrigation Using Antimicrobial-corticosteroid Mixture Versus Cryotherapy on Post-instrumentation Pain and Microbial Reduction in Patients Having Single Canal - Teeth With Necrotic Pulps: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Postinstrumentation pain
研究概览
简要总结
The aim of this study is to compare the effect of antimicrobial-corticosteroid mixture and cryotherapy as final root canal irrigating solutions on post-instrumentation pain in single-canal teeth with necrotic pulps.
详细描述
The trial participants are patients with single-canal teeth with necrotic pulps undergoing root canal treatment on two visits. During the 1st visit, access cavity, root canal cleaning and shaping using rotary files and 2.5% NaOCl irrigation. After apical preparation, a final flush with either a levofloxacin-fluconazole-dexamethasone mixture or cold saline will be used then the tooth access cavity will be sealed with a temporary filling. After the first visit, the participants will be given a pain chart with a numerical rating scale to rate their pain levels from zero to 10 at 6, 12, 24, and 48 hours. Three microbial swabs will be collected for each participant: before instrumentation (S1), after instrumentation before final irrigation (S2), and after final irrigation (S3). After collecting data from all participants, statistical analysis will be conducted to compare the pain intensity and microbial load reduction percentages between the two groups.
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)
盲法说明
Both final irrigating solutions are colorless and will be delivered inside the root canal using a plastic syringe without the patient knowing the type of solution used.
The microbial samples will be sent to the lab for microbial count assessment with a code without identification of the type of irrigating solution used.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in good physical health; American Society of Anesthesiologists class I or II.
- •Patients whose age ranges between 18 and 50 years.
- •Male and female patients.
- •Patients having a single canal-tooth with necrotic pulp.
- •Patients who can understand the number rating scale (figure).
- •Patients who accept to participate in the trial and can sign the informed consent (figure).
排除标准
- •Pregnant females.
- •Patients with swelling.
- •Patients whose tooth is non-restorable.
- •Teeth with open apices.
- •Teeth with radiographic evidence of root resorption.
研究组 & 干预措施
Antimicrobial Corticosteroid mixture
Each canal will receive 5 minutes of final irrigation with the antimicrobial-corticosteroid solution of a freshly prepared mixture of:
1 ml of Levofloxacin (Tavanic, Sanofi Aventis, Egypt).
1 ml of Fluconazole (Sunny fungal, Sunny pharmaceuticals, Egypt).
1 ml of Dexamethasone sodium phosphate (Dexamethasone, Amriya, Egypt).
干预措施: Local anaesthetic injection of 4% articaine with 1:100000 epinephrine (Procedure)
Antimicrobial Corticosteroid mixture
Each canal will receive 5 minutes of final irrigation with the antimicrobial-corticosteroid solution of a freshly prepared mixture of:
1 ml of Levofloxacin (Tavanic, Sanofi Aventis, Egypt).
1 ml of Fluconazole (Sunny fungal, Sunny pharmaceuticals, Egypt).
1 ml of Dexamethasone sodium phosphate (Dexamethasone, Amriya, Egypt).
干预措施: Tooth isolation (Procedure)
Antimicrobial Corticosteroid mixture
Each canal will receive 5 minutes of final irrigation with the antimicrobial-corticosteroid solution of a freshly prepared mixture of:
1 ml of Levofloxacin (Tavanic, Sanofi Aventis, Egypt).
1 ml of Fluconazole (Sunny fungal, Sunny pharmaceuticals, Egypt).
1 ml of Dexamethasone sodium phosphate (Dexamethasone, Amriya, Egypt).
干预措施: Access cavity preparation (Procedure)
Antimicrobial Corticosteroid mixture
Each canal will receive 5 minutes of final irrigation with the antimicrobial-corticosteroid solution of a freshly prepared mixture of:
1 ml of Levofloxacin (Tavanic, Sanofi Aventis, Egypt).
1 ml of Fluconazole (Sunny fungal, Sunny pharmaceuticals, Egypt).
1 ml of Dexamethasone sodium phosphate (Dexamethasone, Amriya, Egypt).
干预措施: Root canal shaping and cleaning (Procedure)
Antimicrobial Corticosteroid mixture
Each canal will receive 5 minutes of final irrigation with the antimicrobial-corticosteroid solution of a freshly prepared mixture of:
1 ml of Levofloxacin (Tavanic, Sanofi Aventis, Egypt).
1 ml of Fluconazole (Sunny fungal, Sunny pharmaceuticals, Egypt).
1 ml of Dexamethasone sodium phosphate (Dexamethasone, Amriya, Egypt).
干预措施: Final irrigation with antimicrobial-corticosteroid mixture (Procedure)
Antimicrobial Corticosteroid mixture
Each canal will receive 5 minutes of final irrigation with the antimicrobial-corticosteroid solution of a freshly prepared mixture of:
1 ml of Levofloxacin (Tavanic, Sanofi Aventis, Egypt).
1 ml of Fluconazole (Sunny fungal, Sunny pharmaceuticals, Egypt).
1 ml of Dexamethasone sodium phosphate (Dexamethasone, Amriya, Egypt).
干预措施: Temporary restoration and patient's instructions (Procedure)
Antimicrobial Corticosteroid mixture
Each canal will receive 5 minutes of final irrigation with the antimicrobial-corticosteroid solution of a freshly prepared mixture of:
1 ml of Levofloxacin (Tavanic, Sanofi Aventis, Egypt).
1 ml of Fluconazole (Sunny fungal, Sunny pharmaceuticals, Egypt).
1 ml of Dexamethasone sodium phosphate (Dexamethasone, Amriya, Egypt).
干预措施: Root canal obturation (Procedure)
Cryotherapy
Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
干预措施: Local anaesthetic injection of 4% articaine with 1:100000 epinephrine (Procedure)
Cryotherapy
Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
干预措施: Tooth isolation (Procedure)
Cryotherapy
Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
干预措施: Access cavity preparation (Procedure)
Cryotherapy
Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
干预措施: Root canal shaping and cleaning (Procedure)
Cryotherapy
Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
干预措施: Final irrigation with cold saline (Procedure)
Cryotherapy
Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
干预措施: Temporary restoration and patient's instructions (Procedure)
Cryotherapy
Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
干预措施: Root canal obturation (Procedure)
结局指标
主要结局
Postinstrumentation pain
时间窗: At 48 hours after the 1st visit
Pain as reported by the patient on a Numerical rating scale from 0 to 10 where 0 indicates no pain and 10 indicates the worst possible pain
Postinstrumentation pain
时间窗: At 6 hours after the 1st visit
Pain as reported by the patient on a Numerical rating scale from 0 to 10 where 0 indicates no pain and 10 indicates the worst possible pain
Postinstrumentation pain
时间窗: At 12 hours after the 1st visit
Pain as reported by the patient on a Numerical rating scale from 0 to 10 where 0 indicates no pain and 10 indicates the worst possible pain
Postinstrumentation pain
时间窗: At 24 hours after the 1st visit
Pain as reported by the patient on a Numerical rating scale from 0 to 10 where 0 indicates no pain and 10 indicates the worst possible pain
次要结局
- Anti bacterial effect(At 24 hours after the 1st visit)
- Antifungal effect(At 48 hours after the 1st visit)
研究者
Mohammed Fawzy Omar Mohammed Habib
Principal investigator
Cairo University