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

NCT07084194 | Not Yet Recruiting DMC

• 1 other identifier: EC Reaseach NO.1079
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain; Flare up; Flare Up, Symptom

Keywords

postoperative pain; flare up; nano-technology; irrigation; chitosan; aloe-vera

Outcome Measures

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.

  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.

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

Study Arms (4)

GROUP I

EXPERIMENTAL

treated with nanochitosan and passive ultrasonic activation

Other: Chitosan Nanoparticles Irrigant; Device: ultrasonic activator

GROUP II

EXPERIMENTAL

treated with nanochitosan and laser activation

Other: Chitosan Nanoparticles Irrigant; Device: Diode Laser Activation

GROUP III

EXPERIMENTAL

treated with nano-Aloe Vera and passive ultrasonic activation

Other: aloe vera nanoparticles irrigant; Device: ultrasonic activator

GROUP IV

EXPERIMENTAL

treated with nano-Aloe Vera and laser activation

Other: aloe vera nanoparticles irrigant; Device: Diode Laser Activation

Interventions

Chitosan Nanoparticles Irrigant OTHER

using Chitosan Nanoparticles irrigant as a final irrigation solution.

GROUP I; GROUP II

aloe vera nanoparticles irrigant OTHER

using Aloe Vera Nanoparticles irrigant as a final irrigation solution.

GROUP III; GROUP IV

Diode Laser Activation DEVICE

activation of nanoparticles irrigants using diode laser

GROUP II; GROUP IV

ultrasonic activator DEVICE

activation of nanoparticles irrigants using ultrasonic activator

GROUP I; GROUP III

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Pain, Postoperative; Symptom Flare Up

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rabee Ibrahaim Alhabibi

CONTACT

+201018836570; rabieibrahaim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rabee Alhabibi

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 24, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07