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Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment

Primary Purpose

Periapical Periodontitis, Root Canal Infection

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
three irrigation activation methods
conventional needle irrigation
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Periodontitis focused on measuring Chronic apical periodontitis, irrigation activation methods, periapical index, postoperative pain, treatment outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Istanbul Medipol University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

three irrigation activation methods

Conventional needle irrigation (control)

Arm 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.

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.

Outcomes

Primary Outcome Measures

change from baseline postoperative pain at 1 week
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.
change from baseline periapical index at 1 year
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 .

Secondary Outcome Measures

Full Information

First Posted
June 14, 2019
Last Updated
June 18, 2019
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03990584
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis, Root Canal Infection
Keywords
Chronic apical periodontitis, irrigation activation methods, periapical index, postoperative pain, treatment outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
three irrigation activation methods
Arm Type
Experimental
Arm 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.
Arm Title
Conventional needle irrigation (control)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
three irrigation activation methods
Other Intervention Name(s)
passive ultrasonic irrigation (Irrisafe; Satelec Acteon, Mérignac, France), sonic irrigation (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA), manual dynamic irrigation (Kerr Dental, USA)
Intervention Description
passive ultrasonic irrigation, sonic irrigation, manual dynamic irrigation
Intervention Type
Procedure
Intervention Name(s)
conventional needle irrigation
Intervention Description
conventional needle irrigation
Primary Outcome Measure Information:
Title
change from baseline postoperative pain at 1 week
Description
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.
Time Frame
24 hours, 48 hours and 1 week postoperatively
Title
change from baseline periapical index at 1 year
Description
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 .
Time Frame
Clinical and radiographic examinations were performed on the 1 day of treatment,1 day after treatment and 1 year after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda Ersahan, PhD
Organizational Affiliation
Istanbul Medipol University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University, Faculty of Dentistry
City
Istanbul
State/Province
Esenler
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After its publication in a journal, we want to share our data
IPD Sharing Time Frame
After its publication in a journal, we want to share our data
IPD Sharing Access Criteria
postoperative pain scores periapical and panoramic radiographs and radiographic findings clinical findings
Citations:
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.
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Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment

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