Clinical trial NCT03990584: Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment
Official title: Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment in Posterior Teeth With Chronic Apical Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Periodontitis
Root Canal Infection
Keywords: Chronic apical periodontitis
irrigation activation methods
periapical index
postoperative pain
treatment outcome
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using different methods of irrigation activation.

Detailed description: Aim: To evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using different methods of irrigation activation.

Methodology: In this prospective clinical trial, root-canal treatment was performed on 162 posterior teeth with chronic apical periodontitis. After routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (CNI) without activation or to one of 3 treatment groups, each of which was treated using a different activation protocol during the final irrigation \[manual dynamic irrigation (MDI), passive ultrasonic irrigation (PUI), sonic irrigation (SI)\]. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 24h, 48h and 7 days using a modified 4-step visual analogue scale (VAS). Patients were recalled at 12 months for clinical and radiographic examinations. Periodontal healing was evaluated using a periapical index (PAI), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. Data were analyzed using one-way ANOVA and Kruskal-Wallis tests, with differences of P \< 0.05 considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* a non-contributory medical history
* must have an asymptomatic, necrotic premolar or molar with periapical lesions of \> 2.0 x 2.0 mm around one or both roots
* must be diagnosed as chronic apical periodontitis

Exclusion Criteria:

* Those with clinical symptoms (acute pain)
* have periapical radiolucency of \>5 mm
* no previous endodontic treatment
* no severe periodontal disease in the related tooth
* non-restorable tooth
* use of any analgesics within the previous 3 days or antibiotics within the previous month

Primary outcomes:
measure: change from baseline postoperative pain at 1 week
timeFrame: 24 hours, 48 hours and 1 week postoperatively
measure: change from baseline periapical index at 1 year
timeFrame: Clinical and radiographic examinations were performed on the 1 day of treatment,1 day after treatment and 1 year after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University, Faculty of Dentistry
state: Esenler
Study officials:
affiliation: Istanbul Medipol University Hospital
name: Seyda Ersahan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrabi SM, Kumar A, Zia A, Iftekhar H, Alam S, Siddiqui S. Effect of passive ultrasonic irrigation and manual dynamic irrigation on smear layer removal from root canals in a closed apex in vitro model. Journal of Investigative and Clinical Dentistry 5: 188-93, 2014. Akerblom A, Hasselgren G. The prognosis for endodontic treatment of obliterated root canals. Journal of Endodontics 14: 565-7, 1998. Attar S, Bowles WR, Baisden MK, Hodges JS, McClanahan SB. Evaluation of pretreatment analgesia and endodontic treatment for postoperative endodontic pain. Journal of Endodontics 34: 652-5, 2008. Brito PR, Souza LC, Machado de Oliveira JC et al. Comparison of the effectiveness of three irrigation techniques in reducing intracanal Enterococcus faecalis populations: an in vitro study. Journal of Endodontics 35: 1422-7, 2009. Brynolf I (1967) A histological and roentgenological study of the periapical region of human upper incisors. Odontologisk Revy 18, 1-176.1-176. Cameron JA (1988) The effect of ultrasonic endodontics on the temperature of the root canal wall. Journal of Endodontics 14, 554-8. Card SJ, Sigurdsson A, Ørstavik D, Trope M . The effectiveness of increased apical enlargement in reducing intracanal bacteria. Journal of Endodontics 28: 779-83, 2002. de Gregorio C, Estevez R, Cisneros R, Heilborn C, Cohenca N . Effect of EDTA, sonic, and ultrasonic activation on the penetration of sodium hypochlorite into simulated lateral canals: an in vitro study. Journal of Endodontics 35: 891-5, 2009. de Gregorio C, Estevez R, Cisneros R, Paranjpe A, Cohenca N . Efficacy of different irrigation and activation systems on the penetration of sodium hypochlorite into simulated lateral canals and up to working length: an in vitro study. Journal of Endodontics 36: 1216-1221, 2010. Desai P, Himel V .Comparative safety of various intracanal irrigation systems. Journal of Endodontics 35: 545-9, 2009.