Postoperative PainNCT07084194
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 study testing Chitosan Nanoparticles Irrigant, aloe vera nanoparticles irrigant and Diode Laser Activation in people with Postoperative Pain and Flare up, run by Minia University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Flare up, Flare Up, Symptom
- What is being tested?
- Chitosan Nanoparticles Irrigant, aloe vera nanoparticles irrigant and Diode Laser Activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2025to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- single root canals or double root.
- Root canal calcifications.
- Root resorption or fracture.
- Previously root canal treated teeth.
- immunocompromised patients.
- Pregnant females
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- Chitosan Nanoparticles Irrigant, aloe vera nanoparticles irrigant, Diode Laser Activation, ultrasonic activator
- Keywords
- postoperative pain, flare up, nano-technology, irrigation, chitosan, aloe-vera
- Medical subject headings
- Pain, Postoperative, Symptom Flare Up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitosan Nanoparticles IrrigantOther
using Chitosan Nanoparticles irrigant as a final irrigation solution.
aloe vera nanoparticles irrigantOther
using Aloe Vera Nanoparticles irrigant as a final irrigation solution.
Diode Laser ActivationDevice
activation of nanoparticles irrigants using diode laser
ultrasonic activatorDevice
activation of nanoparticles irrigants using ultrasonic activator
| Study group | Role | What they receive |
|---|---|---|
| GROUP I | Experimental | treated with nanochitosan and passive ultrasonic activation Receives: Other: Chitosan Nanoparticles Irrigant; Device: ultrasonic activator |
| GROUP II | Experimental | treated with nanochitosan and laser activation Receives: Other: Chitosan Nanoparticles Irrigant; Device: Diode Laser Activation |
| GROUP III | Experimental | treated with nano-Aloe Vera and passive ultrasonic activation Receives: Other: aloe vera nanoparticles irrigant; Device: ultrasonic activator |
| GROUP IV | Experimental | treated with nano-Aloe Vera and laser activation Receives: Other: aloe vera nanoparticles irrigant; Device: Diode Laser Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [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.
This could require an unscheduled emergency visit or prescription of additional medication.
Measured: [Time Frame: Within 7 days post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start10 Sep 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabee Ibrahaim Ismail Alhabibi, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084194
- Sponsor's protocol ID
- EC Reaseach NO.1079
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07084194
- Acronym / sponsor ID
- EC Reaseach NO.1079
- Conditions
- Postoperative Pain, Flare up, Flare Up, Symptom
- Keywords
- postoperative pain, flare up, nano-technology, irrigation, chitosan, aloe-vera
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GROUP I | Experimental | Other: Chitosan Nanoparticles Irrigant, Device: ultrasonic activatortreated with nanochitosan and passive ultrasonic activation |
| GROUP II | Experimental | Other: Chitosan Nanoparticles Irrigant, Device: Diode Laser Activationtreated with nanochitosan and laser activation |
| GROUP III | Experimental | Other: aloe vera nanoparticles irrigant, Device: ultrasonic activatortreated with nano-Aloe Vera and passive ultrasonic activation |
| GROUP IV | Experimental | Other: aloe vera nanoparticles irrigant, Device: Diode Laser Activationtreated with nano-Aloe Vera and laser activation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- single root canals or double root.
- Root canal calcifications.
- Root resorption or fracture.
- Previously root canal treated teeth.
- immunocompromised patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitosan Nanoparticles Irrigantusing Chitosan Nanoparticles irrigant as a final irrigation solution. | Other | GROUP I, GROUP II |
| aloe vera nanoparticles irrigantusing Aloe Vera Nanoparticles irrigant as a final irrigation solution. | Other | GROUP III, GROUP IV |
| Diode Laser Activationactivation of nanoparticles irrigants using diode laser | Device | GROUP II, GROUP IV |
| ultrasonic activatoractivation of nanoparticles irrigants using ultrasonic activator | Device | GROUP I, GROUP III |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Chitosan Nanoparticles Irrigant, aloe vera nanoparticles irrigant and Diode Laser Activation in people with Postoperative Pain and Flare up, run by Minia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rabee Ibrahaim Alhabibi (+201018836570, rabieibrahaim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.