Evaluation of Postoperative Pain With Eddy Tips (EPPET)

NCT03946306 | Completed DMC

• 2 other identifiers: EDDYSP2019-001705-24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

ENDODONTIC IRRIGATION, ENDODONTIC DISINFECTION, EDDY TIPS, APICAL EXTRUSION, ENDODONTIC PAIN

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

5,25% NaOCl with syringe needle irrigation alone

Drug: 5,25% NaOCl with syringe needle irrigation alone

Group 2

ACTIVE COMPARATOR

5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany)

Device: EDDY

Interventions

5,25% NaOCl with syringe needle irrigation alone DRUG

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.

Also known as: NaOCl

Group 1

EDDY DEVICE

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.

Also known as: EDDY + NaOCl

Group 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculdade de Medicina Dentária da Universidade do Porto

Porto, 4200-393, Portugal

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Cláudia Rodrigues, PhD

  Faculdade de Medicina Dentária da Universidade do Porto

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will not know which treatment they will receive
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The 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)

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 10, 2019
• Study Start: February 13, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 27, 2021
• Last Updated: June 7, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)