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

July 16, 2025 updated by: Rabee Ibrahaim Ismail Alhabibi, Minia University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP I
treated with nanochitosan and passive ultrasonic activation
Other: Chitosan Nanoparticles Irrigant
using Chitosan Nanoparticles irrigant as a final irrigation solution.
Device: ultrasonic activator
activation of nanoparticles irrigants using ultrasonic activator
Experimental: GROUP II
treated with nanochitosan and laser activation
Other: Chitosan Nanoparticles Irrigant
using Chitosan Nanoparticles irrigant as a final irrigation solution.
Device: Diode Laser Activation
activation of nanoparticles irrigants using diode laser
Experimental: GROUP III
treated with nano-Aloe Vera and passive ultrasonic activation
Device: ultrasonic activator
activation of nanoparticles irrigants using ultrasonic activator
Other: aloe vera nanoparticles irrigant
using Aloe Vera Nanoparticles irrigant as a final irrigation solution.
Experimental: GROUP IV
treated with nano-Aloe Vera and laser activation
Device: Diode Laser Activation
activation of nanoparticles irrigants using diode laser
Other: aloe vera nanoparticles irrigant
using Aloe Vera Nanoparticles irrigant as a final irrigation solution.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
[Time Frame: Within 7 days post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 10, 2026

Study Registration Dates

First Submitted

July 8, 2025

First Submitted That Met QC Criteria

July 16, 2025

First Posted (Actual)

July 24, 2025

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC Reaseach NO.1079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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