Dental Pulp NecrosisNCT07546773
Metagenomic Analysis and Postoperative Pain in Infected Root Canals Using Different Irrigation Protocols
A study testing Ultrasonic Irrigation Activation, Laser-Activated Irrigation and Mechanical Irrigation Activation in people with Dental Pulp Necrosis and Pulpitis, run by Suez Canal University at 1 site in Egypt.
Trial summary
Achieving effective root canal disinfection while minimizing postoperative pain is a critical goal in endodontic therapy. Advanced irrigation protocols, such as ultrasonic activation, laser activation, negative pressure irrigation (PulpSucker device), and mechanical activation (Easy Clean device), have shown promise… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dental Pulp Necrosis, Pulpitis
- What is being tested?
- Ultrasonic Irrigation Activation, Laser-Activated Irrigation and Mechanical Irrigation Activation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2026to 15 Jan 2028
- Phase
- Interventional
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18-60 years
- Requiring root canal treatment for teeth with necrotic pulp
- Presence of periapical radiolucency confirmed radiographically
- Good general health with no systemic diseases affecting healing outcomes
- Willing to provide informed written consent
- Available for follow-up appointments
Who cannot join
- Patients with open apices
- Severe periodontal disease
- Currently taking antibiotics
- Allergy to study materials (lidocaine, sodium hypochlorite, methylene blue, latex)
- Pregnant or breastfeeding women
- Compromised immunity or systemic conditions (e.g., uncontrolled diabetes, HIV, immunosuppressive therapy)
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- Previous root canal treatment on the study tooth
- Tooth not restorable
- Presence of vertical root fracture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Endodontic Clinic, Faculty of Dentistry, Suez Canal University
Ismailia, Ismailia Governorate, 41522
Salma Mohamed Hassan Gohar, MSc, 00201157445565, Salma_gohar@dent.suez.edu.eg
Hayam Youssef Hassan, Professor, PhD, +20 1227609611
About this study
Official title: Metagenomic Analysis and Post-operative Pain Assessment of Infected Root Canals Using Different Irrigation Protocols: A Randomized Controlled Clinical Trial
Achieving effective root canal disinfection while minimizing postoperative pain is a critical goal in endodontic therapy. Advanced irrigation protocols, such as ultrasonic activation, laser activation, negative pressure irrigation (PulpSucker device), and mechanical activation (Easy Clean device), have shown promise in enhancing bacterial reduction within the root canal system. However, their impact on postoperative pain has not been fully explored.
This randomized controlled clinical trial aims to compare bacterial reduction and postoperative pain levels in infected root canals using four different irrigation protocols. The study will use metagenomic analysis to evaluate changes in bacterial community composition and the Visual Analogue Scale (VAS) to assess patient-reported pain levels at multiple time points postoperatively.
Read the detailed description
Background: Effective bacterial reduction in root canals remains a significant challenge in endodontics due to complex bacterial communities, including species like Enterococcus faecalis that resist conventional treatment methods. Advanced irrigation protocols offer innovative solutions by disrupting biofilms and ensuring deeper penetration of irrigants into apical regions of the canal system.
Study Design: This is a randomized, parallel-group clinical trial involving 40 adult patients (18-60 years) requiring root canal treatment for teeth with necrotic pulp and periapical radiolucency. Patients will be randomly assigned to one of four irrigation protocol groups (10 patients per group):
Group 1: Ultrasonic Activation
Group 2: Laser Activation with methylene blue
Group 3: Mechanical Activation (Easy Clean device)
Group 4: Negative Pressure Irrigation (PulpSucker device)
Procedures: All patients will undergo standardized root canal preparation using rotary nickel-titanium files. Pre-irrigation bacterial samples will be collected before instrumentation, and post-irrigation samples will be collected after the irrigation protocol. All samples will undergo next-generation sequencing (NGS) for metagenomic analysis to assess bacterial reduction and community composition changes.
Outcomes: Postoperative pain will be evaluated using the Visual Analogue Scale (VAS) at 6 hours, 24 hours, 48 hours, and 7 days post-treatment. Statistical analyses will compare bacterial reduction efficacy and pain levels across all four groups.
- Conditions
- Dental Pulp Necrosis, Pulpitis
- Being tested
- Ultrasonic Irrigation Activation, Laser-Activated Irrigation, Mechanical Irrigation Activation, Negative Pressure Irrigation
- Keywords
- Root canal treatment, Irrigation protocol, Ultrasonic activation, Laser activation, Negative pressure irrigation, Mechanical activation, Metagenomic analysis, Postoperative pain, Visual analogue scale, Bacterial reduction, Endodontics, PulpSucker, Easy clean device, Next generation sequencing
- Medical subject headings
- Dental Pulp Necrosis, Pulpitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Irrigation ActivationProcedure or surgery
Also called Group-I
Sodium hypochlorite irrigation activated with ultrasonic device
Laser-Activated IrrigationProcedure or surgery
Also called Group-II
Laser-activated sodium hypochlorite with methylene blue photosensitizer
Mechanical Irrigation ActivationProcedure or surgery
Mechanical activation device creating swirling motion
Negative Pressure IrrigationProcedure or surgery
Continuous irrigation with negative pressure suction
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Activation | Experimental | Root canals will be irrigated with sodium hypochlorite (NaOCl) activated using an ultrasonic device (Ultramint with R17 tip). Receives: Procedure: Ultrasonic Irrigation Activation |
| ARM 2: Laser Activation | Experimental | Root canals will be irrigated with NaOCl activated using a diode laser device (Elexxon Pico, Germany) with methylene blue (0.1 mg/mL) as a photosensitizer to enhance antimicrobial effects. Receives: Procedure: Laser-Activated Irrigation |
| ARM 3: Mechanical Activation (Easy Clean) | Experimental | Root canals will be irrigated with NaOCl, activated mechanically using the Easy Clean device (BassiEndo) to create a swirling motion for improved disinfection. Receives: Procedure: Mechanical Irrigation Activation |
| ARM 4: Negative Pressure Irrigation (PulpSucker) | Experimental | Root canals will be irrigated with NaOCl using the PulpSucker device (PlanB dental), which employs negative pressure irrigation to ensure continuous delivery and debris removal. Receives: Procedure: Negative Pressure Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome 1: Bacterial Reduction
Change in bacterial load (CFU/mL or relative abundance via metagenomic sequencing). Bacterial samples collected before and after irrigation protocol using sterile paper points, analyzed via next-generation sequencing (NGS) to assess bacterial reduction and changes in microbial community composition
Measured: Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation)
Outcome 2: Postoperative Pain Level
Patient-reported pain intensity using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-9=severe tolerable pain, 10=severe intolerable pain.
Measure: Visual Analogue Scale (VAS) score (0-10 scale)
Measured: 6 hours, 24 hours, 48 hours, and 7 days post-treatment
Secondary outcomes (2)
Bacterial Community Composition
Changes in bacterial diversity and species abundance via metagenomic analysis. Next-generation sequencing analysis to identify changes in bacterial species composition and microbial diversity indices.
Measured: Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation)
Correlation Between Bacterial Reduction and Pain
Statistical correlation coefficient between bacterial load reduction and VAS scores. Pearson or Spearman correlation analysis to evaluate relationship between irrigation efficacy and postoperative pain levels.
Measured: Post-irrigation bacterial analysis correlated with pain scores at 6 hours, 24 hours, 48 hours, and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp NecrosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single (Outcomes Assessor) Explanation: Patients and clinician cannot be blinded to irrigation method, but laboratory personnel analyzing bacterial samples and statisticians can be blinded to group allocation.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma gohar, Suez Canal University
- Investigators
- Salah El-Din Mohamed Abdallah, Professor, PhD, Study director, Professor of Microbiology, Faculty of Pharmacy, Suez Canal UniversityHayam Youssef Hassan, Professor, PhD, Study chair, Professor of Endodontics, Faculty of Dentistry, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546773
- Sponsor's protocol ID
- REC 928/2024
- Other IDs
- REC 928/2024
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided