Combining ultrasonic cleaning and a 980 nm diode laser to reduce pain and bacteria after root canal treatment

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

This trial will test whether adding ultrasonic activation plus a 980 nm diode laser during root canal treatment reduces post‑operative pain and bacterial load in adults aged 20–35 with single‑rooted necrotic teeth and small periapical lesions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 20 Years to 35 Years
• Sex: All
• Sponsor: Al-Azhar University (other)
• Locations: 1 site (Cairo)
• Trial ID: NCT07041736 on ClinicalTrials.gov

What this trial studies

This is a parallel randomized controlled trial following PRIRATE 2020 guidelines that enrolls adults (20–35 years) with single‑rooted necrotic teeth and periapical radiolucencies up to 5 mm. Participants are randomized into treatment groups receiving conventional irrigation, ultrasonic activation, 980 nm diode laser, or the combination of ultrasonic activation with the diode laser. The trial measures postoperative pain as the primary clinical outcome and quantifies antibacterial effect by bacterial sampling. Ethical approval and informed consent procedures were completed at the Faculty of Dental Medicine for Girls, Al‑Azhar University.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20–35 with mature, single‑rooted, restorable teeth that have necrotic pulp and a periapical radiolucency up to 5 mm and who are asymptomatic.

Not a fit: Patients with symptomatic apical periodontitis, systemic disease, physical or mental disability, root fracture, or tooth mobility (and those who do not meet the age/tooth criteria) are excluded and likely would not benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination approach could lower pain after treatment and reduce bacterial levels, improving healing and patient comfort.

How similar studies have performed: Previous laboratory and clinical work show that diode lasers and ultrasonic activation can reduce bacterial counts, but clinical evidence for consistent reductions in postoperative pain is mixed and combination therapy remains less well established.

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.

Where this trial is running

Cairo

• from the outpatient clinic of Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University — Cairo, Egypt (RECRUITING)

Study contacts

• Principal investigator: Sabah M. Sobhy, PHD — Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egyp
• Study coordinator: Sabah M. Sobhy, PHD

Conditions: Post Operative Pain