Evaluating Postoperative Pain and Antibacterial Effect of Ultrasonic and 980 nm Diode Laser Combination

Official title

A Randomized Controlled Trial Evaluating Postoperative Pain and Antibacterial Effect of Ultrasonic and 980 nm Diode Laser Combination

Overview

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

• Device diode 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.
• Other conventional irrigation
  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
• Device Diode 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.
• Device Ultrasonic
  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

Primary outcome measures

• Postoperative pain evaluation [Time frame: after 24,48 and 72hours of the treatment]

Secondary outcome measures (1)

• Microbiological analysis [Time frame: 24,48 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• from the outpatient clinic of Endodontic Department, Faculty of Dental Medicine for Girls, — Cairo

Publications

• Dragana R, Jelena M, Jovan M, Biljana N, Dejan M. Antibacterial efficiency of adjuvant photodynamic therapy and high-power diode laser in the treatment of young permanent teeth with chronic periapical periodontitis. A prospective clinical study. Photodiagnosis Photodyn Ther. 2023 Mar;41:103129. doi: 10.1016/j.pdpdt.2022.103129. Epub 2022 Sep 23. PMID 36156313
• Ghonem Z A, Mustafa MH, Shishiny A. Antibacterial Efficacy of Diode laser 810nm on Enterococcus Faecalis on Primary Teeth, an invitro study. Al-Azhar Journal of Dentistry. 2024; 11: 32-8. doi.org/10.58675/2974-4164.1623.
• Nair PN. Pathogenesis of apical periodontitis and the causes of endodontic failures. Crit Rev Oral Biol Med. 2004 Nov 1;15(6):348-81. doi: 10.1177/154411130401500604. PMID 15574679
• Fahim SZ, Ghali RM, Hashem AA, Farid MM. The efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in root canal disinfection: A randomized clinical trial. Clin Oral Investig. 2024 Feb 26;28(3):175. doi: 10.1007/s00784-024-05563-z. PMID 38403667

Identifiers

NCT: NCT07041736 · P-PD-25-12

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗