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NCT Number: NCT07084194

Impact of Integrating Two Nano Based Irrigants With Two Activation Techniques in Treatment of Teeth With Acute Pulpitis on Postoperative Pain and Flare up Incidence

This study aimed to evaluate and compare impact of integrating passive ultrasonic activation and laser activation with nano-chitosan and aloe vera in terms of postoperative pain and flare-up incidence in a randomized clinical trial.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-60 (adults only)
  • multiple-rooted with multiple root canal.
  • Permanent teeth with mature apex and complete root formation.
  • Without root caries.
  • Tooth must be restorable.
  • Without anatomical abnormalities such as fusion.
  • Healthy patient category I according to ASA.
  • Vital tooth, with acute irreversible pulpitis and without peri-apical periodontitis.
  • No periapical radiolucency.
  • Consent Patients for who consent to participate and attend follow-up appointments.

Exclusion criteria

  • single root canals or double root.
  • Root canal calcifications.
  • Root resorption or fracture.
  • Previously root canal treated teeth.
  • immunocompromised patients.
  • Pregnant females
  • Patients with systemic diseases as diabetic or hypertension patients.
  • Patients with facial swelling.
  • patients who use analgesics or antibiotics within 48-72 hours.
  • Allergy to any materials used (e.g., irrigants or anesthetics).
  • psychiatric illness
  • Teeth that are not indicated for endodontic treatment: bad oral hygiene, mobile teeth, or recessed teeth.
  • Previously endodontically treated teeth.
  • Teeth with sinus tract.

Treatment and study plan

Chitosan Nanoparticles Irrigant

Other

using Chitosan Nanoparticles irrigant as a final irrigation solution.

aloe vera nanoparticles irrigant

Other

using Aloe Vera Nanoparticles irrigant as a final irrigation solution.

Diode Laser Activation

Device

activation of nanoparticles irrigants using diode laser

ultrasonic activator

Device

activation of nanoparticles irrigants using ultrasonic activator

Primary outcomes

  1. postoperative pain intensity Postoperative pain is to be assessed using visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10 means a severe pain that has never faced before.

    Time frame: [Time Frame: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.]

    Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.

Secondary outcomes

  1. Flare-Up Incidence Flare-up is assessed through asking the patient to notify the investigator if any sudden severe pain or swelling takes place.

    Time frame: [Time Frame: Within 7 days post-treatment)

    This could require an unscheduled emergency visit or prescription of additional medication.

Study contacts

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

Rabee Ibrahaim Alhabibi

CONTACT

[email protected]

+201018836570

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Impact of Integrating Two Nano Based Irrigants With Two Activation Techniques in Treatment of Teeth With Acute Pulpitis on Postoperative Pain and Flare up Incidence: A Randomized Clinical Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

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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