Evaluation of Postoperative Pain With Eddy Tips (EPPET)

• ClinicalTrials.gov Identifier: NCT03946306
• Recruitment Status: Unknown
• First Posted: May 10, 2019
• Last Update Posted: May 10, 2019
• Sponsor: Universidade do Porto
• Information provided by (Responsible Party): Universidade do Porto

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative	Drug: 5,25% NaOCl with syringe needle irrigation alone; Device: EDDY	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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)
• Masking: Single (Participant)
• Masking Description: The patients will not know which treatment they will receive
• Primary Purpose: Prevention
• Official Title: Comparative Evaluation of Postoperative Pain,Periapical Damage and Bacterial Disinfection After Using Endodontic Needle and Eddy Tips During Root Canal Irrigation
• Estimated Study Start Date: May 2019
• Estimated Primary Completion Date: November 2019
• Estimated Study Completion Date: December 2019

Arms and Interventions

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 Name: 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 Name: EDDY + NaOCl

Outcome Measures

Primary Outcome Measures :

1. Evaluation of postoperative pain change during the first 48 hours after treatment [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Sara Paixão, MSc; +351 912415188; asrpaixao@gmail.com

Contact: Cláudia Rodrigues, PhD; +351 912142680; crodrigues@fmd.up.pt

Sponsors and Collaborators

Universidade do Porto

Investigators

• Study Chair: Cláudia Rodrigues, PhD; Faculdade de Medicina Dentária da Universidade do Porto

More Information

• Responsible Party: Universidade do Porto
• ClinicalTrials.gov Identifier: NCT03946306
• Other Study ID Numbers: EDDYSP; 2019-001705-24 ( EudraCT Number )
• First Posted: May 10, 2019
• Last Update Posted: May 10, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidade do Porto:

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

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations