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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
from the outpatient clinic of Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University
RECRUITING
Cairo
Contact Information
Primary
Sabah M. Sobhy, PHD
sabamorad@yahoo.com
+201096529143
Time Frame
Start Date: 2025-08-03
Estimated Completion Date: 2026-02-15
Participants
Target number of participants: 120
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: Al-Azhar University

This content was sourced from clinicaltrials.gov