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Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment

M

Medipol Health Group

Status

Completed

Conditions

Root Canal Infection
Periapical Periodontitis

Treatments

Procedure: conventional needle irrigation
Procedure: three irrigation activation methods

Study type

Interventional

Funder types

Other

Identifiers

NCT03990584
10840098-604.01.01-E34148

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

150 participants in 2 patient groups

three irrigation activation methods
Experimental group
Description:
Manual dynamic irrigation was performed using a well-fitting gutta-percha cone inserted to WL with in-and-out vertical strokes of 5 mm at a rate of approximately 100 strokes per minute in order to hydrodynamically displace the irrigant. Passive ultrasonic irrigation was performed using a non-cutting size 25 file attached to a piezoelectric ultrasonic unit. Sonic irrigation was performed using an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA). A suitable-size activator tip was selected and loosely placed at 2 mm from working length, and the device was operated at 10,000 cycles/min using a pumping action to move the tip to produce vertical strokes of 2-3 mm.
Treatment:
Procedure: three irrigation activation methods
Conventional needle irrigation (control)
Active Comparator group
Description:
Conventional needle irrigation was performed with short, in-and-out vertical strokes of 2-3 mm at a rate of approximately 100 strokes per minute.
Treatment:
Procedure: conventional needle irrigation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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