Antibacterial Efficacy and Outcomes of Root Canal Irrigation Methods

Обзор

This randomized clinical trial aims to evaluate the antibacterial efficacy and treatment outcomes of three different final irrigation protocols during root canal therapy: 2.5% sodium hypochlorite alone, sodium hypochlorite with Passive Ultrasonic Irrigation (PUI), and sodium hypochlorite with XP-Endo Finisher activation. Sixty-six single-rooted teeth with pulp necrosis and apical periodontitis will be randomly assigned to one of the three groups. Antibacterial efficacy will be assessed through Real-Time PCR quantification of total bacterial load and four specific bacterial species before and after treatment. Treatment success will be evaluated clinically and radiographically at 6 and 12 months. The study aims to identify the most effective irrigation strategy for bacterial reduction and healing outcomes.

Подробное описание

This randomized, two-arm, parallel clinical trial investigates the antibacterial effectiveness and clinical outcomes of three root canal final irrigation protocols in teeth with pulp necrosis and apical periodontitis. Following standard chemomechanical preparation, participants' teeth will be randomly assigned to one of three interventions: final irrigation with 2.5% sodium hypochlorite alone, sodium hypochlorite activated by Passive Ultrasonic Irrigation (PUI) or sodium hypochlorite activated with the XP-Endo Finisher file.

The study focuses on the reduction of total bacterial load and specific pathogenic bacterial species (Pseudoramibacter alactolyticus, Treponema denticola, Streptococcus anginosus, and Porphyromonas endodontalis ) assessed through highly sensitive quantitative Real-Time PCR analysis of samples collected at different treatment stages. Sampling procedures ensure strict aseptic conditions and standardized protocols for DNA extraction and analysis.

All participants will undergo a standardized endodontic treatment protocol by a single operator to minimize variability. Follow-up includes clinical and radiographic examinations at 6 and 12 months, with healing assessed through the Periapical Index (PAI) and presence or absence of clinical symptoms.

This trial aims to provide new clinical evidence regarding the added value of supplementary irrigation techniques, comparing their ability to reduce bacterial burden and influence long-term treatment success.

Вмешательства

• Процедура Final Irrigation with 2.5% Sodium Hypochlorite
  After supragingival scaling and removal of caries or defective restorations, the tooth will be isolated and disinfected with 3% H202 and 2.5% NaOCl. Access preparation will be done using a sterile high-speed bur under sterile saline irrigation, followed by re-disinfection. NaOCl will be neutralized with 5% sodium thiosulphate, and sterility will be confirmed via paper point sampling. Only teeth with negative sterility samples will proceed. Sample S1 will be collected after saline irrigation and
• Процедура Passive Ultrasonic Irrigation (PUI) with Sodium Hypochlorite
  Activation of 2.5% sodium hypochlorite solution inside the root canal system using Passive Ultrasonic Irrigation (PUI) after chemomechanical preparation. Group B, sample (S3).
• Процедура XP-Endo Finisher Activation with Sodium Hypochlorite
  Mechanical activation of 2.5% sodium hypochlorite solution using the XP-Endo Finisher instrument following chemomechanical preparation.Group C, sample (S3).

Первичные конечные точки

• Reduction in Total Intracanal Bacterial Load [Срок оценки: 0ne to six months]

Вторичные конечные точки (2)

• Reduction in Specific Bacterial Species [Срок оценки: one to six months]
• Clinical and Radiographic Healing Outcome [Срок оценки: 6 months and 12 months after root canal treatment]

Критерии участия

Критерии включения

• Informed consent by the patients who wish to participate in the study.
• Single-rooted teeth with pulp necrosis confirmed by pulp sensibility tests, negative response to both cold and electric pulp testing and radiographic evidence of apical periodontitis.
• Teeth with relatively straight canals, complete root development and no radiographic evidence of pulp canal obliteration.

Критерии исключения

• Patients who have received antibiotic treatment the last 3 months or need chemoprophylaxis for dental treatment.
• Teeth with previous endodontic treatment.
• Teeth with cracks or incomplete vertical root fracture which disturbs the integrity of the pulp chamber walls or teeth with the pulp chamber exposed to oral environment.
• Teeth with periodontal pocket more than 4mm.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Греция · 1 центр

• National and Kapodistrian University of Athens — Athens

Публикации

• Orstavik D. Root canal disinfection: a review of concepts and recent developments. Aust Endod J. 2003 Aug;29(2):70-4. doi: 10.1111/j.1747-4477.2003.tb00515.x. PMID 14655819
• Siqueira JF Jr, Rocas IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod. 2008 Nov;34(11):1291-1301.e3. doi: 10.1016/j.joen.2008.07.028. Epub 2008 Sep 17. PMID 18928835
• Luciano Giardino, Marco Morra, Carlo Becce, Fernanda G. Pappen, Zahed Mohammadi, Flavio Palazzi,Comparative wettability of different sodium hypochlorite solutions,Giornale Italiano di Endodonzia.2012; 26(22):1121-4171 doi:org/10.1016/j.gien.2012.06.002.
• Weber CD, McClanahan SB, Miller GA, Diener-West M, Johnson JD. The effect of passive ultrasonic activation of 2% chlorhexidine or 5.25% sodium hypochlorite irrigant on residual antimicrobial activity in root canals. J Endod. 2003 Sep;29(9):562-4. doi: 10.1097/00004770-200309000-00005. PMID 14503827
• Mohammadi Z, Abbott PV. Antimicrobial substantivity of root canal irrigants and medicaments: a review. Aust Endod J. 2009 Dec;35(3):131-9. doi: 10.1111/j.1747-4477.2009.00164.x. PMID 19961451
• Ricucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod. 2009 Apr;35(4):493-502. doi: 10.1016/j.joen.2008.12.014. PMID 19345793
• Sjogren U, Figdor D, Persson S, Sundqvist G. Influence of infection at the time of root filling on the outcome of endodontic treatment of teeth with apical periodontitis. Int Endod J. 1997 Sep;30(5):297-306. doi: 10.1046/j.1365-2591.1997.00092.x. PMID 9477818
• Sjogren U, Hagglund B, Sundqvist G, Wing K. Factors affecting the long-term results of endodontic treatment. J Endod. 1990 Oct;16(10):498-504. doi: 10.1016/S0099-2399(07)80180-4. PMID 2084204

Идентификаторы

NCT: NCT06959602 · 691/18.02.2025 · Giorge Tzanetakis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗