Evaluation of Postoperative Pain With Eddy Tips (EPPET)

Comparative Evaluation of Postoperative Pain,Periapical Damage and Bacterial Disinfection After Using Endodontic Needle and Eddy Tips During Root Canal Irrigation

This investigation will focus on the use of EDDY tips, because it is known that the complete debridement of the canal is very difficult, which leads to an accumulation of tissue debris, bacteria and their products, resulting in persistent periradicular inflammation. So, it's of great importance, the study of other approaches of cleaning and disinfecting the root canal, which at the same time, may produce a lower risk of postoperative pain.

The above mentioned topics have never been analysed simultaneously with the use of EDDY tips, and the evaluation of the postoperative pain was never addressed.

This research is of great clinical interest, due to the complexity of root canal system, with isthmuses, ramifications and dentinal tubules, that make the total elimination of bacteria impossible, even with the best clinical protocols, because the irrigants cannot penetrate the dentinal tubules, and the postoperative pain is an exhausting factor for patients.

Therefore, a new protocol, with better disinfection rate and less postoperative pain, will be able to increase the success rate of endodontic treatments, allowing to save condemned teeth.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: 5,25% NaOCl with syringe needle irrigation alone; Device: EDDY

Detailed Description

CLINICAL STUDY:

1. Rate of postoperative pain of 2 endodontic disinfection protocols.

-A clinical study will be carried out, in patients that attend the Faculdade de Medicina Dentária Dental Clinic at Universidade do Porto, for initial nonsurgical root canal treatments. About 80 single-rooted and premolar teeth with mature, fully formed apices and diagnosed with irreversible pulpitis will be selected.

Patients will be excluded if they were <12 years of age; pregnant; had an indication for antibiotic prophylaxis; uncontrolled hypertension or diabetes mellitus; chronic renal failure; hematologic diseases; HIV; osteoporosis treated with bisphosphonates; steroid therapy >5mg/day of prednisolone and prior to head and neck irradiation therapy. We will also exclude teeth with abnormal root canal anatomy, with more than 26mm in length and with advanced periodontal disease. Those patients will be divided in 2 groups: Group 1: (control group) 5,25% NaOCl with syringe needle irrigation alone. Group 2: 5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany)

All the patients will receive anaesthetic solution and after anaesthesia, each tooth will be isolated using rubber dam and the access cavity will be made.

The glide path will be determined using stainless steel hand files, confirmed by periapical radiographs. The root canals will be instrumented, confirming the apical patency with a size 15 K-file, and then the instrumentation sequence. The apical patency will be maintained throughout the shaping procedure using #10 k-file between each instrument.

• All the canals will be irrigated continuously with 5,25% NaOCl during the instrumentation, with a conventional endodontic syringe with 27 gauge needle. In group 1 (control group), a final irrigation will be made with 1.5 ml of NaOCl per canal, during 30 seconds in an up-and-down motion, with the needle 1 mm short of the working length, without binding. After this, a 30 seconds pause will be done. This step will be repeated once again. In group 2, a final irrigation will be made with 1.5 ml of NaOCl per canal and the irrigant will be activated using EDDY tips, 1 mm short of the working length without binding. The activation will be performed during 30 seconds, followed by a 30 seconds pause, and the cycle will be repeated once again, according to manufacture instructions.
• After the final irrigation protocol, all the canals will be dried and sterile cotton pellets will be placed in the pulp chamber with a provisional restoration. No intracanal medicament will be placed. The obturation will be executed in the following appointment.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-393
    • Faculdade De Medicina Dentaria da Universidade do Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• About 80 single-rooted and premolar teeth with mature, fully formed apices and diagnosed with irreversible pulpitis will be selected.

Exclusion Criteria:

• Patients will be excluded if they were <12 years of age; pregnant; had an indication for antibiotic prophylaxis; uncontrolled hypertension or diabetes mellitus; chronic renal failure; hematologic diseases; HIV; osteoporosis treated with bisphosphonates; steroid therapy >5mg/day of prednisolone and prior to head and neck irradiation therapy. We will also exclude teeth with abnormal root canal anatomy, with more than 26mm in length and with advanced periodontal disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 5,25% NaOCl with syringe needle irrigation alone	Drug: 5,25% NaOCl with syringe needle irrigation alone; In group 1 (control group), a final irrigation will be made with 1.5 ml of NaOCl per canal, during 30 seconds in an up-and-down motion, with the needle 1 mm short of the working length, without binding. After this, a 30 seconds pause will be done. This step will be repeated once again.; Other Names: NaOCl
Active Comparator: Group 2; 5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany)	Device: EDDY; In group 2, a final irrigation will be made with 1.5 ml of NaOCl per canal and the irrigant will be activated using EDDY tips, 1 mm short of the working length without binding. The activation will be performed during 30 seconds, followed by a 30 seconds pause, and the cycle will be repeated once again, according to manufacture instructions.; Other Names: EDDY + NaOCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of postoperative pain change during the first 48 hours after treatment	All patients will receive a paper with a visual analogue scale, to score their pain from 0 to 10. None of the patients will have analgesics prescribed immediately after the treatment. They will be advised to not take any medication at any point of the follow-up. If they need some advice or analgesic medication, they will be able to contact with the investigator. The investigator will reach the patients after 8, 24 and 48 h, in order to ask their pain intensity and to ask if they need to take any analgesic to stop the pain. In case of any patient mentioning an important pain, it will be advised to take Ibuprofen 600mg every 6 hours, until the pain disappears. If any patient is allergic to non-steroidal anti-inflammatories, they will be advised to take paracetamol 1g and not take more than 4g per day. All the controls will be recorded on each patient's chart.	first 48 hours after treatment

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Investigators: Study Chair: Cláudia Rodrigues, PhD, Faculdade De Medicina Dentaria da Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 27, 2021

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: ENDODONTIC IRRIGATION, ENDODONTIC DISINFECTION, EDDY TIPS, APICAL EXTRUSION, ENDODONTIC PAIN
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: EDDYSP; 2019-001705-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No