Evaluation of the Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 36
- 主要终点
- Post-operative pain
研究概览
简要总结
Evaluation of the effect of cryotherapy versus post-operative ibuprofen medication on post-operative pain in mandibular molar teeth with symptomatic irreversible pulpitis .
a new technique was proposed to utilize the effect of cold saline on reducing the inflammatory process in the tissue, the so-called cryotherapy.
详细描述
PICO/
Population: Molar teeth with symptomatic irreversible pulpitis. Intervention I: Final irrigation with cold saline (cryotherapy). Intervention II: Ibuprofen post-operative medication.
Control: Final irrigation with normal saline, and no post-operative medication. Outcome: Post- operative pain.
Sequence of Procedural steps:
- Full medical and dental history will be obtained from all the patients .
- Thorough clinical and radiographic examination for the tooth to be treated will be done.
- The tooth will be anaesthetized and Access cavity will be performed.
- The canals will be thoroughly irrigated using 3ml syringe of Sodium hypochlorite after every instrument.
- Canals will be dried using sterile paper points.
- In the intervention group 1, cryotherapy irrigation will be done using 20ml of 2.5°C cold saline for 5 min, the cold saline will be stored in an icebox with a thermometer calibrated at 2.5°C.
- In the intervention group 2, the patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
- In the control group, final irrigation will be done using normal saline at room temperature.
- Canals will be dried using sterile paper points, and then filled with gutta percha cones corresponding to the same size of the final shaping file and sealed with sealer.
- The access cavity will then be closed with temporary filling.
- Post-operative instructions will be given to all patients. • The patient will be asked to rate their pain level according to the given instructions and telecommunication will be scheduled after 3 days to collect the VAS scores and assess the outcome of the treatment. The patients who will be suffered from severe pain, analgesic will be prescribed.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients above 18 years old and to
- •Male or female.
- •Patients seeking root canal treatment.
- •Molar teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura.
- •Systematically healthy patient (ASA I).
- •Patient who can understand VAS and sign informed consent.
排除标准
- •Medically compromised patients having significant systemic disorders including cardiovascular, respiratory, and gastrointestinal diseases (ASA II, III or IV).
- •History of intolerance to NSAIDS.
- •Patients with two or more adjacent teeth requiring endodontic treatment.
- •External root resorption.
- •Internal root resorption.
- •Vertical root fracture.
- •Periapical lesion.
- •Pregnancy.
- •Use of ibuprofen in the last 12 hour.
- •Bleeding disorder.
- •Long term corticosteroid use. 10
- •Mobility Grade II or III.
- •Pocket depth more than 5mm.
- •Previous root canal therapy.
- •Non-restorability.
- •TMJ problems, bruxism, clenching or traumatic occlusion.
- •Inability to perceive the given instructions.
研究组 & 干预措施
Final irrigation with cold saline (cryotherapy).
20ml of 2.5°C cold saline for 5 min
干预措施: cold saline (cryotherapy) (Other)
Ibuprofen post-operative medication.
a single dose of Ibuprofen 400 mg immediately after completion of root canal treatment
干预措施: Ibuprofen 400 mg (Drug)
Final irrigation with normal saline, and no post-operative medication
final irrigation will be done using normal saline at room temperature.
干预措施: Final irrigation with normal saline (Other)
结局指标
主要结局
Post-operative pain
时间窗: 48 hours post-operatively
The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" * 1-3, "mild pain" * 4-6, "moderate pain" * 7-10, "severe pain" "10" being the most intense pain conceivable.
次要结局
未报告次要终点
研究者
Yousef Hassan Mohammed Abuhelal
Principal Investigator
Cairo University