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

NCT07041736 | Recruiting DMC

• 1 other identifier: P-PD-25-12
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain evaluation

  Postoperative pain will be recorded using numerical rating scale (NRS) with minimum value 0 and maximum value 10 (worst pain).

  after 24,48 and 72hours of the treatment

Secondary Outcomes (1)

• Microbiological analysis

  24,48 hours

Study Arms (4)

Group I (conventional group)

EXPERIMENTAL

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.

Other: conventional irrigation

Group II (Diode laser group)

EXPERIMENTAL

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.

Device: diode laser

Group III (Ultrasonic group)

EXPERIMENTAL

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

Device: Ultrasonic

Group IV Ultrasonic+Diode

EXPERIMENTAL

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

Device: Diode laser; Device: Ultrasonic

Interventions

conventional irrigation OTHER

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

Group I (conventional group)

Diode laser DEVICE

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.

Group II (Diode laser group)

Ultrasonic DEVICE

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

Group III (Ultrasonic group); Group IV Ultrasonic+Diode

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with symptomatic apical periodontitis.
• Systemic disease.
• Physical or mental disability.
• Root fracture and tooth mobility.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

from the outpatient clinic of Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Egypt

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lasers, Semiconductor; Ultrasonography

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sabah M. Sobhy, PHD

  Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egyp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabah M. Sobhy, PHD

CONTACT

+201096529143; sabamorad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Healthcare and research

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 27, 2025
• Study Start: August 3, 2025
• Primary Completion: April 15, 2026
• Study Completion: May 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)