Post Operative Pain
Conditions
Brief summary
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.
Detailed description
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%.
Interventions
DEVICEdiode laser
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.
After each file use, the root canal will be irrigated with 5ml of freshly prepared 2.5% sodium hypochlorite (NaOCl) solution (Alex. Deteregents and Chemical Co., Egypt) for 1 minute using a 31-gauge Navi-Tip flexible irrigating needle (Navi-Tip, Ultradent product, South Jourdan, UT). 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 solutio
DEVICEDiode laser
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.
DEVICEUltrasonic
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
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
this randomized controlled clinical trial included 120 patients that have single rooted teeth with necrotic pulp and periapical radioluceny. Patients were randomly assigned to receive root canal disinfection using either conventional techniquediode laser, ultrasonic irrigation, or a combination of both.
Eligibility
Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients with symptomatic apical periodontitis. * Systemic disease. * Physical or mental disability. * Root fracture and tooth mobility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain evaluation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological analysis | 24,48 hours | Microbiological analysis of samples (S1\&S2) will be performed to evaluate the percentage of reduction in the number of Colony Forming Units (CFU) of aerobic and anaerobic bacteria. |
Countries
Egypt
Contacts
CONTACTSabah M. Sobhy, PHD
PRINCIPAL_INVESTIGATORSabah M. Sobhy, PHD
Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egyp
Outcome results
None listed