Pulp Necrosis, Apical Periodontitis
Conditions
Keywords
Root Canal Irrigation, Metronidazole, Nano-formulated Metronidazole, Ultrasonic Activation, Post-operative Pain, Endotoxin
Brief summary
This randomized controlled clinical trial evaluates the effect of conventional metronidazole and nano-formulated metronidazole as root canal irrigants, with and without ultrasonic activation, in patients with necrotic single-rooted teeth associated with apical periodontitis. A total of 60 participants will be randomly allocated into six equal groups according to the irrigant used and whether ultrasonic activation is performed. Sodium hypochlorite will be used as the conventional control irrigant. The study will compare the groups regarding post-operative pain and reduction in root canal endotoxin levels. Post-operative pain will be assessed using a Visual Analogue Scale, while endotoxin levels will be measured before and after treatment using an ELISA assay
Detailed description
Effective disinfection of the root canal system is an essential part of successful non-surgical root canal treatment. However, microorganisms and their by-products, including endotoxins, may persist within inaccessible areas of the root canal system and may contribute to post-operative pain and persistent periapical inflammation. This single-center, randomized, controlled, parallel-group clinical trial is designed to compare conventional metronidazole and nano-formulated metronidazole irrigation with sodium hypochlorite in necrotic single-rooted teeth with apical periodontitis. The study also evaluates the effect of ultrasonic activation on the performance of each irrigant. Sixty participants will be randomly allocated into six equal groups. The three irrigants evaluated are 2.5% sodium hypochlorite, 0.5% metronidazole, and 0.5% nano-formulated metronidazole. Each irrigant will be evaluated with and without ultrasonic activation using the Ultra X device. Root canal preparation and irrigation procedures will be standardized for all participants. The primary clinical outcome is post-operative pain, assessed using a 0-to-10 Visual Analogue Scale at 6, 12, 24, 48, and 72 hours after treatment. The biological outcome is the change in root canal endotoxin levels. Samples will be collected before instrumentation and after completion of the irrigation protocol, and endotoxin levels will be quantified using an ELISA assay.
Interventions
DRUGMetronidazole 0.5%
Metronidazole 0.5% solution will be used as a root canal irrigant during chemo-mechanical preparation, with or without ultrasonic activation according to the assigned study group.
DRUGNano-formulated Metronidazole 0.5%
Nano-formulated metronidazole 0.5% solution will be used as a root canal irrigant during chemo-mechanical preparation, with or without ultrasonic activation according to the assigned study group.
Sodium hypochlorite 2.5% solution will be used as the conventional gold-standard root canal irrigant during root canal preparation, with or without ultrasonic activation according to the assigned study group.
DEVICEUltra X Ultrasonic Activation
Ultrasonic activation of the assigned root canal irrigant will be performed using the Ultra X device (Eighteeth) for 30 seconds per cycle according to the manufacturer's instructions.
Sponsors
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomly allocated to six parallel groups with an allocation ratio of 1:1:1:1:1:1
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 21 and 50 years. * Patients requiring non-surgical root canal treatment. * Single-rooted permanent teeth with necrotic pulp. * Teeth diagnosed with apical periodontitis. * Teeth with fully formed apices. * Patients medically free or with a controlled systemic condition. * Patients able to understand the Visual Analogue Scale (VAS).
Exclusion criteria
* Patients with systemic diseases affecting healing, such as uncontrolled diabetes or immunocompromised patients. * Patients who received antibiotics or anti-inflammatory drugs within the last 48 hours. * Pregnant or lactating women. * Previously endodontically treated teeth (retreatment cases). * Teeth with root resorption, open apex, root fracture, or severe canal calcification.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Score | 6, 12, 24, 48, and 72 hours postoperatively | Post-operative pain will be assessed using a 0-10 Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Endotoxin Levels | Baseline (before instrumentation) and immediately after completion of the final irrigation protocol during the same treatment visit. | Endotoxin levels will be quantified using an ELISA assay and expressed as endotoxin units per milliliter (EU/mL). Reduction will be calculated by comparing baseline and post-treatment values. |
Countries
Egypt
Contacts
CONTACTMariam S Abdelfattah, BDS
STUDY_CHAIRMostafa Shaker, PhD
October 6 University
Outcome results
None listed