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临床试验/NCT04035083
NCT04035083Unknown不适用

Evaluation of Post-operative Pain and Bacterial Reduction Following Laser Activated Irrigation Versus Passive Ultrasonic Irrigation in Necrotic Single Rooted Teeth: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 44 人开始时间: 2019年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
44
主要终点
Post-operative pain 48 hours post-operatively: NRS

研究概览

简要总结

assessment of bacterial reduction and post-operative pain following Laser activated irrigation using sodium hypochlorite and a 980 nm diode laser device as an adjunct to conventional root canal treatment, and comparing it with passive ultrasonic irrigation using sodium hypochlorite and an ultrasonic device in patients with single rooted asymptomatic necrotic teeth.

详细描述

After thorough diagnosis and recording of the patient's perceived preoperative pain using the numeric rating scale (NRS), which should be zero. Patients with single rooted necrotic teeth will be randomly divided into two groups for endodontic treatment in a single visit:

Group LAI (in which laser activated irrigation will be done) and group PUI (in which passive ultrasonic irrigation will be done).

The teeth are anesthetized and isolation is done. the clamp, tooth crown and rubber dam are disinfected using 2.5% sodium hypochlorite and 30% hydrogen peroxide then sodium thiosulphate to neutralize their effects.

Removal of caries and defective restorations is done, followed by access cavity preparation using round burs and fine tapered stones. then the first microbiological sample is taken using paper points. Afterwards root canal preparation is done using Protaper Next files and irrigation is done using 2.5% sodium hypochlorite and a 30 -gauge side vented needle.

After chemomechanical preparation of the canal, the second microbiological sample is taken, afterwards the canals are filled with sodium hypochlorite and according to the group, the following is done:

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)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Medically free patients.
  • Patients with necrotic pulp in single rooted teeth with:
  • Closed apex.
  • Associated with or without periapical radiolucency.
  • No response of vital pulp with the electric pulp tester.
  • Healthy dental and periodontal status.
  • Positive patients' acceptance for participation in the study.
  • Exclusion Criteria i. Patients on medication for chronic pain. ii. Patients with pre-operative pain. iii. Patients having significant systemic disorders. iv. Patients with two or more adjacent teeth requiring root canal therapy. v. Patients who had received antibiotics in the last month. vi. Teeth that have:
  • Vital pulp tissues.
  • Association with swelling or fistulous tract.
  • Acute peri-apical abscess.
  • Greater than grade I mobility.
  • Pocket depth greater than 5mm.
  • No possible restorability.
  • Previous endodontic treatment.
  • Open apex.
  • Extra coronal restorations.

排除标准

  • 未提供

研究组 & 干预措施

Laser activated irrigation

Experimental

Laser activated irrigation of sodium hypochlorite using a 980 nm diode laser device

干预措施: Laser activated irrigation (Device)

Passive ultrasonic irrigation

Active Comparator

passive ultrasonic irrigation of sodium hypochlorite using an ultrasonic laser device

干预措施: Passive ultrasonic irrigation (Device)

结局指标

主要结局

Post-operative pain 48 hours post-operatively: NRS

时间窗: 48 hours after endodontic treatment

Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)

Post-operative pain 6 hours post-operatively: NRS

时间窗: 6 hours after endodontic treatment

Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)

Post-operative pain 12 hours post-operatively: NRS

时间窗: 12 hours after endodontic treatment

Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)

Post-operative pain 24 hours post-operatively: NRS

时间窗: 24 hours after endodontic treatment

Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)

次要结局

  • change in intracanal bacterial flora count(48 hours after endodontic treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Ayman Abo El Enin Ahmed

Assistant lecturer

Cairo University

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