Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment

NCT03990584 | Completed DMC

• 1 other identifier: 10840098-604.01.01-E34148
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Periapical Periodontitis; Root Canal Infection

Keywords

Chronic apical periodontitis; irrigation activation methods; periapical index; postoperative pain; treatment outcome

Outcome Measures

Primary Outcomes (2)

• 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.

  24 hours, 48 hours and 1 week postoperatively

• 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 .

  Clinical and radiographic examinations were performed on the 1 day of treatment,1 day after treatment and 1 year after treatment.

Study Arms (2)

three irrigation activation methods

EXPERIMENTAL

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

Conventional needle irrigation (control)

ACTIVE COMPARATOR

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

Interventions

three irrigation activation methods PROCEDURE

passive ultrasonic irrigation, sonic irrigation, manual dynamic irrigation

Also known as: passive ultrasonic irrigation (Irrisafe; Satelec Acteon, Mérignac, France), sonic irrigation (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA), manual dynamic irrigation (Kerr Dental, USA)

three irrigation activation methods

conventional needle irrigation PROCEDURE

conventional needle irrigation

Conventional needle irrigation (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Seyda Ersahan, PhD

  Istanbul Medipol University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 19, 2019
• Study Start: February 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2019
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After its publication in a journal, we want to share our data
• Access Criteria: postoperative pain scores periapical and panoramic radiographs and radiographic findings clinical findings

Locations

TU (1)