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NCT Number: NCT07041736

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

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.

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Key information

Conditions

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

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Egypt

Location status: Recruiting

Location contact

Sabah M. Sobhy, PHD

CONTACT

[email protected]

01096529143

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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

Primary outcomes

  1. Postoperative pain evaluation

    Time frame: 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 outcomes

  1. Microbiological analysis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabah M. Sobhy, PHD

CONTACT

[email protected]

+201096529143

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: Postoperative

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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