A Randomized Controlled Trial Evaluating Postoperative Pain and Antibacterial Effect of Ultrasonic and 980 nm Diode Laser Combination
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative pain evaluation
研究概览
简要总结
This study is a parallel randomized controlled clinical trial that was designed and interpreted according to Preferred Reporting Items for Randomized Trial in Endodontics (PRIRATE) 2020 guidelines. Patients of age range between 20 and 35 years old from the outpatient clinic of Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University will participate in this study. These patients have single rooted teeth with necrotic pulp and periapical radiolucency. Patients will be informed about all the study's procedures. They will be included in the study after fulfilling the inclusion criteria and sign an informed consent.Inclusion Criteria:
- Patients have mature teeth with closed apex.
- Single rooted teeth with root canal form type I.
- Asymptomatic.
- Have Periapical radiolucency with diameter up to 5 mm.
- Restorable teeth.
Exclusion Criteria:
- Patients with symptomatic apical periodontitis.
- Systemic disease.
- Physical or mental disability.
- Root fracture and tooth mobility.
详细描述
Ethical approval for the human study was obtained by the Research Ethics Committee (REC) of the Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt . All patients were provided with an informed consent form outlining the study's details including potential benefits and risks, which they read and signed prior to participation. Sample size calculation was performed using G*Power version 3.1.9.7 based on the results of a previous study . A power analysis was designed to have adequate power to apply a two-sided statistical test to reject the null hypothesis that there is no difference between groups. By adopting an alpha level of (0.05) and a beta of (0.2), i.e. power = 80% and an effect size (d) of (0,332) calculated based on the primary outcome (Postoperative pain) and the results of a previous study. The predicted sample size (n) was (104), i.e., 26 subjects per group. This number is increased to 30 subjects per group to compensate for a drop-out rate of 15%.
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
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have mature teeth with closed apex.
- •Single-rooted teeth with root canal form type I.
- •Asymptomatic.
- •Have periapical radiolucency with a diameter of up to 5 mm.
- •Restorable teeth.
排除标准
- •Patients with symptomatic apical periodontitis.
- •Systemic disease.
- •Physical or mental disability.
- •Root fracture and tooth mobility.
研究组 & 干预措施
Group I (conventional group)
Access cavity preparation will be performed under strict aseptic condition and rubber dam isolation. Orifice location will be identified then, microbiological sample (S1) will be taken. The working length will be determined using an electronic apex locator (EAL) and will be confirmed using periapical radiograph. Root canal preparation will be performed using EdgeFile X7 nickel-titanium rotary system ((Edge Endo, Albuquerque, New Mexico, USA) driven by EndoEst motor mini (Geosoft Dent., Russia) endomotor till #40 taper 0.04 file in continuous rotation at 300 rpm and 2 Ncm.
干预措施: conventional irrigation (Other)
Group II (Diode laser group)
The same steps as mentioned in group I up to the use of saline solution for final irrigation. Then, the canal will be irradiated with 980 nm diode laser with optical fiber 200 µm (Lite medics, Italy) and power setting 1.2 watt in pulsed mode. The irradiation protocol will be a 5 sec. irradiation followed by a 10 sec. rest, which constituted one lasing cycle. The lasing cycle will be performed four times for each tooth. Microbiological sample (S2) will be taken after laser application.
干预措施: diode laser (Device)
Group III (Ultrasonic group)
The same as in group I however, during cleaning and shaping ProUltra PiezoFlow (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA.) will be used for activation of the irrigating solution according to the manufacturer's recommendations. The needle will be operated using Satelec P5 Piezoelectric Ultrasonic Unit (Acteon, Mount Laurel, NJ, USA.) at power setting of 5. The stopper on the PiezoFlow needle will be set 1 mm short of binding in the canals, but not more than 75% of the WL. A syringe containing 5 mL of 2.5% NaOCl will be attached to the Piezoflow activation needle and the inactive needle will be inserted in the canal, and irrigant flow will be started before activation. During activation, the needle will be moved up and down passively in the canal (26). 5 ml of 17% EDTA (Colgate Oral Care Company, Waverly, Australia) for 1 min will be used for smear layer removal. 5 ml of saline solution will be used for final irrigation of the root canal to neutralize all the previously used
干预措施: Ultrasonic (Device)
Group IV Ultrasonic+Diode
The same steps as in group III then, 980 nm diode laser irradiation will be applied as in Group II and microbiological sample (S2) will be taken after laser application
干预措施: Diode laser (Device)
Group IV Ultrasonic+Diode
The same steps as in group III then, 980 nm diode laser irradiation will be applied as in Group II and microbiological sample (S2) will be taken after laser application
干预措施: Ultrasonic (Device)
结局指标
主要结局
Postoperative pain evaluation
时间窗: after 24,48 and 72hours of the treatment
Postoperative pain will be recorded using numerical rating scale (NRS) with minimum value 0 and maximum value 10 (worst pain).
次要结局
- Microbiological analysis(24,48 hours)
研究者
Sabah Morad Sobhy
Healthcare and research
Al-Azhar University