Dental Pulp Necrosis, Pulpitis
Conditions
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
Brief 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 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.
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.
Interventions
PROCEDUREUltrasonic Irrigation Activation
Sodium hypochlorite irrigation activated with ultrasonic device
PROCEDURELaser-Activated Irrigation
Laser-activated sodium hypochlorite with methylene blue photosensitizer
PROCEDUREMechanical Irrigation Activation
Mechanical activation device creating swirling motion
PROCEDURENegative Pressure Irrigation
Continuous irrigation with negative pressure suction
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The operator performing treatment must know which irrigation protocol is used (ultrasonic, laser, Easy Clean, PulpSucker), so participants and care providers are not masked. One of your main outcomes is patient-reported pain (VAS), so the participant is the outcome assessor for that endpoint and cannot realistically be blinded
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * Previous root canal treatment on the study tooth * Tooth not restorable * Presence of vertical root fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome 1: Bacterial Reduction | Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation) | 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 |
| Outcome 2: Postoperative Pain Level | 6 hours, 24 hours, 48 hours, and 7 days post-treatment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Community Composition | Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation) | 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. |
| Correlation Between Bacterial Reduction and Pain | Post-irrigation bacterial analysis correlated with pain scores at 6 hours, 24 hours, 48 hours, and 7 days | 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. |
Countries
Egypt
Contacts
CONTACTSalma Mohamed Hassan Gohar, MSc
STUDY_DIRECTORSalah El-Din Mohamed Abdallah, Professor, PhD
Professor of Microbiology, Faculty of Pharmacy, Suez Canal University
STUDY_CHAIRHayam Youssef Hassan, Professor, PhD
Professor of Endodontics, Faculty of Dentistry, Suez Canal University
Outcome results
None listed