Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03990584
Collaborator
(none)
150
1
2
14.9
10.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: three irrigation activation methods
  • Procedure: conventional needle irrigation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment in Posterior Teeth With Chronic Apical Periodontitis
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: three irrigation activation methods

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.

Procedure: three irrigation activation methods
passive ultrasonic irrigation, sonic irrigation, manual dynamic irrigation
Other Names:
  • passive ultrasonic irrigation (Irrisafe; Satelec Acteon, Mérignac, France), sonic irrigation (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA), manual dynamic irrigation (Kerr Dental, USA)
  • Active Comparator: Conventional needle irrigation (control)

    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.

    Procedure: conventional needle irrigation
    conventional needle irrigation

    Outcome Measures

    Primary Outcome Measures

    1. change from baseline postoperative pain at 1 week [24 hours, 48 hours and 1 week postoperatively]

      Pain was measured using a modified visual analogue scale (VAS) with 4 levels, as follows: 1, no pain; 2, slight pain (mild discomfort, no treatment needed); 3, moderate pain (pain required analgesics for relief); 4, severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit). Patients were provided forms and asked to record preoperative pain as well as pain at 24 hours, 48 hours and 1 week postoperatively, and to note down the number of analgesics taken. Patients returned their completed forms at their 1-week follow-up visits.

    2. change from baseline periapical index at 1 year [Clinical and radiographic examinations were performed on the 1 day of treatment,1 day after treatment and 1 year after treatment.]

      Periapical tissue was evaluated using a 5-point periapical index (PAI) (Ørstavik et al. 1986) and scored as follows: 1: Normal periapical structures; 2: Small changes in bone structures; 3: Changes in bone structure with some mineral loss; 4: Periodontitis with well-defined radiolucent area; 5: Severe periodontitis with exacerbating features. If scores varied among roots in the same tooth, the highest score was recorded for that tooth. Similarly, if scores varied between observers for the same tooth, the higher score was recorded. Treatment was considered successful if the patient had no discomfort, no percussion/palpation pain, no sinus tract, no mobility or associated soft-tissue swelling, and a PAI score of ≤ 2. Treatment was considered a failure if the patient could not perform normal masticatory functions, experienced discomfort and percussive pain upon examination, and/or had a PAI score of ≥ 3 .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul Medipol University, Faculty of Dentistry Istanbul Esenler Turkey

    Sponsors and Collaborators

    • Istanbul Medipol University Hospital

    Investigators

    • Principal Investigator: Seyda Ersahan, PhD, Istanbul Medipol University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    seydaersahan, Director, Clinical Research, Istanbul Medipol University Hospital
    ClinicalTrials.gov Identifier:
    NCT03990584
    Other Study ID Numbers:
    • 10840098-604.01.01-E34148
    First Posted:
    Jun 19, 2019
    Last Update Posted:
    Jun 19, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by seydaersahan, Director, Clinical Research, Istanbul Medipol University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 19, 2019