Effect of Low Level Laser Therapy (LLLT) Versus Calcium Hydroxide Intra-canal Medication on Postoperative Pain and Total Amount of Substance P and IL-8 in Periapical Fluids in Patients With Symptomatic Apical Periodontitis: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 主要终点
- incidence of postoperative pain
研究概览
简要总结
a randomized clinical study to compare the effect of using low level laser therapy versus calcium hydroxide intra-canal medication on:
- Incidence and intensity of postoperative pain in patients with symptomatic apical periodontitis.
- The intensity of postoperative percussion pain in patients with symptomatic apical periodontitis
- The total amount of substance P and Interleukin 8 in periapical fluids one week post instrumentation.
详细描述
Diagnosis:
Personal data including name, address and phone number in addition to medical history (Appendix II) and dental history (Appendix III) will be collected by the operator from each patient in specific forms, then history of chief complaint will be recorded. The selected patients should show symptoms of irreversible pulpitis. The operator will perform extra-oral and intra-oral clinical examination as the expected tooth to be included in this study should be examined tentatively using a diagnostic mirror and probe. Radiograph will be taken using bisecting angle technique with a periapical digital sensor plate1. The radiograph will help to identify if there is widening of periodontal ligament space, periapical radiolucency, deep caries near the pulp chamber or recurrent caries under restoration.
The diagnosis of symptomatic apical periodontitis is confirmed through:
- The patient history of pain with biting and confirmed with positive percussion test.
- After completing the diagnosis (symptomatic apical periodontitis) and confirming that the patient fulfills the eligibility criteria, the patient will be enrolled in the study. The treatment will be done in two visits.
Treatment procedure:
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)
盲法说明
The participants will be blinded to the study hypothesis as to which intervention is expected to be better.
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- •Age between 25-50 years old.
- •Males & Females.
- •Single canaled teeth:
- •Diagnosed clinically with symptomatic apical periodontitis.
- •Widening in the periodontal membrane space or with small sized periapical radiolucency
- •Presence of pain with percussion and preoperative percussion pain level will be evaluated and recorded using modified visual analog scale (VAS).
- •Patients' acceptance to participate in the trial.
- •Patients who can understand pain scale and can sign the informed consent
排除标准
- •Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
- •Pregnant women: Avoid radiation exposure, anesthesia, and medication.
- •If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively might alter their pain perception.
- •Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
- •Teeth that shows association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
- •Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
- •No restorability: Hopeless tooth.
- •Immature teeth.
- •Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
结局指标
主要结局
incidence of postoperative pain
时间窗: 24 hours
incidence of postoperative pain will be recorded in pain chart
次要结局
- intensity of postoperative pain: modified visual analogue scale(48 hours)
研究者
Radhwa Refaat Otaify
Principal Investigator
Cairo University